Laser treatment system and method for ocular tissue using non-collinear imaging

Abstract

This invention relates to a system and method of laser treatment using non-collinear imaging in the field of medical devices and the treatment of ophthalmic diseases, including glaucoma. [Solution] A method for treating the 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, wherein the output axis 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 into a portion of the iris-corneal angle at a point along the inscribed angle of the eye. The method also includes imaging a portion of the iris-corneal angle with an OCT beam, and transmitting a laser beam into a target volume of ocular tissue in the iris-corneal angle portion along an angled optical path that extends through the first optical subsystem, through the cornea, and through the anterior chamber, and photodisrupting at least a portion of the target volume of ocular tissue with the laser beam.

Description

[Technical Field]

[0001]

[0001] This disclosure relates in general to the field of medical devices and the treatment of ophthalmic diseases, including glaucoma, and more particularly to a system and method of laser therapy using non-collinear imaging. [Background technology]

[0002]

[0002] Before describing the various types of glaucoma and the current diagnostic and treatment options, we will briefly outline the anatomy of the eye.

[0003]

[0003] Anatomy of the eye

[0004] Referring to Figures 1-3, the outer tissue layer of the eye 1 includes the sclera 2, which provides the structure of the eye's shape. Anterior to the sclera 2 is the cornea 3, which is composed of a transparent tissue layer that allows light to enter the inside of the eye. Inside the 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, transparent fluid called aqueous humor 8. Surrounding the lens 4 is the iris 9, which forms the pupil around the approximate 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 the lens.

[0004]

[0005] Referring to Figure 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. The anatomical structure of the sclerocorneal junction of eye 1 includes the trabecular meshwork 12. The trabecular meshwork 12 is a fibrous network of tissue surrounding the iris 9 within eye 1. Simply put, the tissues of the sclerocorneal junction, in general terms, are arranged as follows: the iris 9 is in contact with the ciliary body 6, the ciliary body is in contact with the lower side of the scleral spine 14, and the upper part of the scleral spine functions as an attachment point to the base of the trabecular meshwork 12. The ciliary body 6 is mainly located in the posterior chamber but extends to the corners of the anterior chamber 7. Because the network of tissue layers constituting the trabecular meshwork 12 is porous, it serves as a drainage pathway for aqueous humor 8 flowing from the anterior chamber 7. This pathway may be referred to herein as the aqueous humor outflow pathway, aqueous humor outflow pathway, or simply the outflow pathway.

[0005]

[0006] Referring to Figure 3, the pathways formed by the pores in the trabecular meshwork 12 lead to a series of thin, porous tissue layers called the uvea 15, the corneoscleral reticular network 16, and the paratubular tissue 17. The paratubular 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 the surrounding tissues and drains it into the venous system through a system of collecting ducts 19. As shown in Figure 2, the vascular layer of the eye called the choroid 20 is adjacent to the sclera 2. A space called the suprachoroidal space 21 may exist between the choroid 20 and the sclera 2. The circumferentially extending region near the wedge-shaped periphery between the cornea 3 and the iris 9 is called the iris-corneal angle 13. The iris-corneal angle 13 is also called the corneal angle of the eye or simply the angle of the eye. All the ocular tissues shown in Figure 3 are thought to be located within the iris-corneal angle 13.

[0006]

[0007] Referring to Figure 4, the two possible outflow pathways for the movement of aqueous humor 8 include the trabecular outflow pathway 40 and the uveoscleral outflow pathway 42. Further referring to Figure 2, the 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 the two different outflow pathways 40, 42. Approximately 90% of the aqueous humor 8 passes through the trabecular meshwork 12 into Schlemm's canal 18, is drained through one or more collecting duct plexuses 19 into the trabecular outflow pathway 40, and then drains into the venous system through the drainage pathway 41. The remaining aqueous humor 8 mainly flows out through the uveoscleral outflow pathway 42. The uveoscleral outflow pathway 42 passes through the surface of the ciliary body 6 and the iris root into the suprachoroidal space 21 (see Figure 2). The aqueous humor 8 is drained from the suprachoroidal space 21 and from there through the sclera 2.

[0007]

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

[0008]

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

[0009]

[0010] Glaucoma

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

[0010]

[0012] Glaucoma has two forms: one is called angle-closure glaucoma, and the other is called open-angle glaucoma. Referring to Figures 1 to 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, the more common form of glaucoma, the permeability of ocular tissue can be affected by irregularities in the inner walls of the proximal canaliculi 17 and Schlemm's canal 18a, and by occlusion of the iris-corneal angle 13 along the trabecular meshwork outflow pathway 40.

[0011]

[0013] As mentioned earlier, elevated intraocular pressure (IOP) can damage the optic nerve and is widely recognized as a risk factor for glaucoma. However, not everyone with elevated IOP will develop glaucoma, and it is possible to develop glaucoma even without elevated IOP. Nevertheless, it is desirable to keep elevated IOP down to reduce the risk of glaucoma.

[0012]

[0014] Methods for diagnosing the eye condition of glaucoma patients include visual acuity and visual field testing, pupil dilation, intraocular pressure measurement, and pachymetry (measurement of corneal thickness). Visual impairment begins with narrowing of the visual field and progresses to complete blindness. Imaging diagnostics include slit-lamp examination, gonioscopy to observe the iris-corneal 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 lower intraocular pressure and slow or stop the progression of glaucoma. The most common treatments are: 1) medication (such as eye drops or tablets), 2) laser surgery, and 3) conventional surgery. Treatment usually begins with medication. However, the effectiveness of medication is often hindered by patient non-compliance. If medication is ineffective, laser surgery is usually the next treatment to be tried. Conventional surgery is more invasive, carries higher risks than medication and laser surgery, and its effects are less long-lasting. Therefore, conventional surgery is usually reserved as a last resort for patients whose intraocular pressure cannot be controlled with medication or laser surgery.

[0014]

[0016] Laser surgery

[0017] Referring to Figure 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 first laser trabeculoplasty. During the procedure, an argon laser with a wavelength of 514 nm is irradiated onto the trabecular meshwork 12 in a range of approximately 180 degrees around the iris-corneal angle 13. The argon laser causes thermal interaction with the ocular tissue, creating an opening in the trabecular meshwork 12. However, ALT causes scarring of the ocular tissue, followed by an inflammatory response and tissue healing, which can eventually close the opening in the trabecular meshwork 12 created by the ALT treatment, thus reducing the effectiveness of the treatment. Furthermore, due to this scarring, ALT therapy is usually not repeatable.

[0016]

[0019] SLT is designed to reduce scarring by selectively targeting pigments within the trabecular meshwork 12 and reducing the amount of heat transmitted to the surrounding ocular tissue. During this procedure, a solid-state laser with a wavelength of 532 nm is irradiated onto the trabecular meshwork 12 in a range of 180 to 360 degrees along the circumference of the iris-corneal angle 13, removing the pigment cells that make up the trabecular meshwork and cover the inside of it. During SLT, the collagen superstructure of the trabecular meshwork is preserved. 12. SLT treatment can be repeated, but the effect of IOP reduction will be less pronounced in subsequent treatments.

[0017]

[0020] ELT utilizes a non-thermal interaction between a 308nm wavelength ultraviolet (UV) excimer laser and ocular tissue to treat the trabecular meshwork 12 and the inner wall of Schlemm's canal 18a in a way that does not trigger a healing response. Therefore, the effect of lowering intraocular pressure lasts longer. However, because the UV light from the laser cannot reach deep into the eye, the laser light is irradiated onto the trabecular meshwork 12 via an optical fiber inserted into the eye 1 through an opening, bringing it into contact with the trabecular meshwork. This procedure is highly invasive and is usually performed simultaneously with cataract surgery when the eye is already open for other surgery. Similar to ALT and SLT, ELT cannot control the amount of IOP reduction. [Overview of the project]

[0018]

[0021] This disclosure relates to a method for imaging and treating an eye having an optical axis, cornea, anterior chamber, and iris-corneal angle. The method involves transmitting an optical coherence tomography (OCT) beam from an OCT imaging device along an OCT optical path, the OCT beam entering a first optical subsystem along the OCT input axis and exiting the first optical subsystem along the OCT output axis. The OCT output axis is substantially parallel to the optical axis of the eye, radially offset from the optical axis of the eye, passes through the cornea, and extends to a portion of the iris-corneal angle at a point along the inscribed angle of the eye. The method further includes imaging a portion of the iris-corneal angle with the OCT beam, irradiating a target volume of ocular tissue in the iris-corneal angle portion with a laser beam passing through the first optical subsystem, cornea, and anterior chamber along an angled optical path, 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, cornea, anterior chamber, and iris-corneal angle. The surgical system includes 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 be connected to an eye, a second optical subsystem optically connected to the laser source, the OCT imaging device, and the first optical subsystem, and a control system connected 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 along an OCT input axis incident on an entrance surface of the first optical subsystem and direct the OCT beam along an OCT optical path through the first optical subsystem to an OCT output axis, where the OCT output axis is 1) substantially parallel to the optical axis of the eye, 2) radially offset from the optical axis of the eye, and 3) at a point along the circumferential angle of the eye, extends through the cornea to a portion of the iridocorneal angle. The first optical subsystem is also configured to receive the incidence of a laser beam along a laser input axis to the entrance surface of the first optical subsystem, pass through the first optical subsystem 1001, through the cornea, and along an angled optical path 706 through the anterior chamber of the eye, and direct it into a target volume of eye tissue in a portion of the iridocorneal angle.

[0021]

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

[0022]

[0025] The present disclosure also relates to a focusing objective lens head configured to be coupled to a patient interface. The patient interface includes a window configured to be coupled to the cornea of an eye. The focusing objective lens head includes an exit lens and a prism mechanically and optically coupled to the exit lens. The exit lens and the prism together form an optical assembly mechanically fixed to the housing of the focusing objective lens head. The exit lens is optically coupled to the window of the patient interface and is configured to align the 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 the prism is configured to receive an OCT beam incident on the entrance surface of the prism along an OCT input axis and direct the OCT beam along an OCT output axis. The OCT output axis is substantially parallel to the axis of the exit lens, radially offset from the axis of the exit lens, extends through the exit lens to the cornea, and extends 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 entrance surface of the exit lens along a laser input axis, pass through the exit lens along an angled optical path, through the cornea, through the anterior chamber of the eye, and direct the laser beam into a target volume of eye 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] Other aspects of the apparatus and method will be apparent to those skilled in the art from the following detailed description, in which various aspects of the apparatus and method are illustrated and described by way of example. As will be appreciated, these aspects may be implemented in other different forms and some of the details may be varied 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 the system, apparatus, and method are presented in the detailed description by way of example and not limitation, with reference to the accompanying drawings.

Brief Description of the Drawings

[0025] [Figure 1]

[0028] This is a schematic cross-sectional view of the human eye and its internal anatomical structure. [Figure 2]

[0029] Figure 1 is a schematic cross-sectional view of the iris and corneal angle of the eye. [Figure 3]

[0030] Figure 2 is a schematic cross-sectional diagram showing in detail the anatomical structure of the corneal corner of the iris, including the trabecular meshwork, Schlemm's canal, and one or more collecting canals branching from Schlemm's canal. [Figure 4]

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

[0032] This is a schematic cross-sectional diagram of the human eye, showing various axes related to the eye. [Figure 6]

[0033] This is a schematic cross-sectional view of two different optical paths, including an angled optical path and a parallel optical path, in which one or more beams may reach the iris-corneal angle of the eye. [Figure 7]

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

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

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

[0037] Figure 9a is a schematic diagram of the embodiment, showing that the focusing objective lens head is detached from the patient interface, and the patient interface is detached from the eye. [Figure 9c]

[0038] Figures 9a and 9b show exploded schematic diagrams of the configuration of the first optical subsystem, which is formed by the optical system of the focusing objective lens head and the patient interface. [Figure 10a]

[0039] This is a schematic diagram of another configuration of the first optical subsystem that can be used instead of the first optical subsystem in Figure 9c. [Figure 10b] Figure 9c is a schematic diagram of other configurations of the first optical subsystem that can be used as an alternative to the first optical subsystem. [Figure 10c] This is a schematic diagram of another configuration of the first optical subsystem that can be used instead of the first optical subsystem in Figure 9c. [Figure 10d] This is a schematic diagram of another configuration of the first optical subsystem that can be used instead of the first optical subsystem in Figure 9c. [Figure 10e1]

[0040] This is an isometric view of the first optical subsystem from a different viewpoint. [Figure 10e2] This is an isometric view of the first optical subsystem from a different viewpoint. [Figure 10e3] This is an isometric view of the first optical subsystem from a different viewpoint. [Figure 11a]

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

[0042] Figure 11a is a schematic diagram of an embodiment showing that the focusing objective lens head is separated from the interface structure, the interface structure is separated from the patient interface, and the patient interface is separated from the eye. [Figure 12a]

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

[0044] Figure 12a is a schematic diagram of an embodiment showing that the focusing objective lens head is separated from the interface structure, the interface structure is separated from the patient interface, and the patient interface is separated from the eye. [Figure 13a]

[0045] Figures 7 and 8 are schematic diagrams of the components of the integrated surgical system functionally arranged to form a first optical subsystem and a second optical subsystem, respectively, which enable access to the iris-corneal angles along the angled and parallel optical paths of Figure 6. [Figure 13b]

[0046] This is a schematic diagram showing a laser beam that passes through the first optical subsystem in Figure 13a, travels along an angled optical path, and enters the eye, and an OCT beam that passes through the first optical subsystem along a parallel optical path. [Figure 14]

[0047] This is a three-dimensional schematic diagram of the anatomical structure of the iris-corneal angle, including the trabecular meshwork, Schlemm's canal, the collector channels branching from Schlemm's canal, and the surgical volume of ocular tissue treated by the integrated surgical system shown in Figure 7. [Figure 15]

[0048] Figure 14 shows a two-dimensional schematic diagram of the anatomical structure of the iris-corneal angle, and Figure 7 shows a three-dimensional laser treatment pattern applied by the integrated surgical system to act on the surgical volume of ocular tissue between Schlemm's canal and the anterior chamber. [Figure 16]

[0049] Figure 14 is a three-dimensional schematic diagram after surgical treatment of the volume of ocular tissue with a laser based on the laser treatment pattern in Figure 15, which creates an opening between Schlemm's canal and the anterior chamber. [Figure 17a]

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

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

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

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

[0054] This is a flowchart of a method for imaging and treating the eye via non-collinear laser and imaging pathways. [Figure 21]

[0055] This is an OCT image that includes images obtained from a circumferential (or tangential) OCT scan and images obtained from a radial OCT scan. [Modes for carrying out the invention]

[0026]

[0056] The integrated surgical system disclosed herein is configured to image and treat an eye having an optical axis, cornea, anterior chamber, and iris-corneal angle. The system includes 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 connect to an 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 its entry surface along the OCT input axis, which 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 the iris-corneal angle at a point along the inscribed angle of the eye. The first optical subsystem is also configured to receive a laser beam incident on its entry surface along the laser input axis and direct it through the first optical subsystem, through the cornea, and through the anterior chamber along an angled optical path into a target volume of ocular tissue in the iris-corneal angle.

[0028]

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

[0029]

[0059] In the integrated surgical system disclosed herein, the OCT beam and the laser beam are directed into the iris-corneal angle of the eye along different optical axes or paths. The laser beam enters the eye through the cornea, passes through the aqueous humor in the anterior chamber, and enters the iris-corneal angle of the eye, where it corrects the target ocular tissue. The OCT beam enters the eye from the cornea to the treatment site, passing through the cornea without passing through the anterior chamber and directly imaging the tissue surrounding the treatment volume, thus avoiding the aqueous humor. Therefore, byproducts of laser-tissue interaction, such as bubbles and / or tissue fragments in the aqueous humor, do not obstruct the view of the OCT beam. In addition, the quality of the OCT image is improved because the OCT beam does not pass through the interface between the trabecular meshwork, cornea, and aqueous humor, thus avoiding aberrations and absorption losses that occur when passing through tissue interfaces.

[0030]

[0060] Laser surgical procedures for treating glaucoma involve imaging of the iris-corneal angle, including the trabecular meshwork. In known laser treatment procedures, OCT imaging may be used to identify the ocular tissue to be treated. In such procedures, the OCT beam can be directed to the iris-corneal angle, passing through a common optical system and collinear with the laser beam along the same optical path. During laser treatment, by-products of the laser treatment, such as bubbles and / or tissue fragments due to laser light disruption, may form in areas of the optical path, obstructing the view of the diagnostic OCT beam and affecting the quality of the OCT image. Furthermore, as the OCT beam passes through various tissue interfaces, aberrations and absorption losses may occur, potentially affecting the quality of the OCT image. Another drawback of directing the OCT beam collinear with the laser beam is the inability to obtain an OCT image with sufficient resolution to identify clinically important features such as Schlemm's canal. This lack of depth penetration may limit the clinical usefulness of the OCT image.

[0031]

[0061] The integrated surgical system disclosed herein directs the OCT beam into the eye in a manner that avoids the byproducts of laser treatment and optical aberrations and absorption caused by ocular 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, photodestructive laser-tissue interaction while minimizing collateral damage to surrounding ocular tissue. In optically transparent tissues, the laser's photodestructive interaction is utilized. The primary mechanism by which laser energy accumulates in ocular tissue is not absorption, but rather a highly nonlinear multiphoton process. This process is effective only at the focal point of a pulsed laser with high peak intensity. Regions through which the beam passes but are not at 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 weakly scattering tissues. While femtosecond lasers with photodestructive interaction have been effectively used in ophthalmic surgical systems and are commercialized for other ophthalmic laser procedures, none have been used in integrated surgical systems that access the iris-corneal angle.

[0033]

[0064] In known refractive surgery procedures, femtosecond lasers are used to create corneal flaps, pockets, tunnels, arcuate incisions, lenticle incisions, and partial or complete corneal incisions for corneal transplantation. In cataract procedures, the laser is used to perform a capsulotomy by making a circular incision in the eye capsule, and to make various patterns of incisions in the lens to break the inside of the lens into small fragments for easier removal. The cornea is incised to open the eye, allowing access with manual surgical instruments, as well as insertion of a phacoemulsifier and intraocular lens implantation device. Several companies commercialize such surgical systems, including the IntraLase system currently sold by Johnson & Johnson Vision in Santa Ana, California; the LenSx and WaveLight systems sold by Alcon in Fort Worth, Texas; the Lensar laser system sold by Lensar, Inc. in Orlando, Florida; the femtolaser family sold by Ziemer Ophthalmics, Alton IL in Alton, Illinois; the Victus femtosecond laser platform sold by Bausch & Lomb in Rochester, New York; and the Catalys precision laser system sold by Johnson & Johnson in Santa Ana, California.

[0034]

[0065] These existing systems have been developed for specific applications, such as surgery on the cornea, lens, and its capsule, and for several reasons, they cannot perform surgery on the iris-corneal angle 13. Firstly, the iris-corneal angle 13 is too far from the periphery and is outside the surgical range of these systems, making it inaccessible to these surgical laser systems. Secondly, the angle of the laser beam from these systems is aligned with the optical axis 24 relative to the eye 1, and is not suitable for reaching the iris-corneal angle 13, where significant scattering and optical distortion occur at the applied wavelength. Thirdly, the imaging capabilities that these systems may possess do not have the accessibility, penetration depth, and resolution necessary to image tissue along the trabecular outflow pathway 40 with sufficient detail and contrast.

[0035]

[0066] According to the integrated surgical system disclosed herein, access to the iris-corneal angle 13 for laser treatment purposes is provided along an angled optical path 30 that forms an angle with respect to the optical axis 24 relative to the eye 1. The tissue along this angled optical path 30, for example, the cornea 3 and aqueous humor 8 in the anterior chamber 7, is transparent to wavelengths of approximately 400 nm to 2500 nm, and a femtosecond laser operating in this region can be used. Such mode-locked lasers operate at the fundamental wavelength using titanium, neodymium, or ytterbium as the active material. By nonlinear frequency conversion techniques, frequency doubling, frequency tripling, summing and difference frequency mixing techniques, and optical parametric conversion known in the art, the fundamental wavelengths of these lasers can be converted to substantially 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, requiring higher pulse energy and resulting in a larger photodisruption interaction area, thus reducing the precision of surgical treatment. However, higher surgical precision is required when treating the iris-corneal angle 13. For this reason, integrated surgical systems can be configured to apply lasers with pulse durations of 10 femtoseconds (fs) to 1 nanosecond (ns) to generate a photodisruption interaction between the laser beam and the ocular tissue of the iris-corneal angle 13. Lasers with pulse durations of less than 10 femtoseconds are available, but such laser sources are more complex and expensive. Lasers with the desired characteristics described, e.g., pulse durations of 10 femtoseconds (fs) to 1 nanosecond (ns), are commercially available from several vendors, including Newport (Irvine, California), Coherent (Santa Clara, California), Amplitude Systems (Pessac, France), and NKT Photonics (Birkerod, Denmark).

[0037]

[0068] OCT Imaging

[0069] The imaging component of the integrated surgical system disclosed herein is an OCT imaging device. OCT technology can be used for the diagnosis, positioning, and guidance of laser surgery on the iris-corneal angle of the eye. For example, referring to Figures 1 to 3, OCT imaging can be used to determine the structural and geometric condition of the anterior chamber 7, assess the possibility of occlusion of the trabecular meshwork outflow pathway 40, and determine the accessibility of ocular tissue for treatment. As previously mentioned, obstruction of aqueous humor flow by the iris 9 in the collapsed anterior chamber 7 can lead to closed-angle glaucoma. In open-angle glaucoma, the macroscopic shape of the angle is normal, but the permeability of ocular tissue may be affected by occlusion of tissue along the trabecular meshwork outflow pathway 40, or collapse of Schlemm's canal 18 or collecting duct 19.

[0038]

[0070] According to the integrated surgical system disclosed herein, access to the iris-corneal angle 13 for the purpose of OCT imaging 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 for OCT imaging yields two-dimensional (2D) cross-sectional images of ocular tissue. As another aspect of the integrated surgical system, 2D cross-sectional images can also be processed and analyzed to determine the size, shape, and location of ocular structures that are targets for surgery. It is also possible to reconstruct three-dimensional (3D) images from a large number of 2D cross-sectional images, but this is often not necessary. Acquisition, analysis, and display of 2D images are faster and can still provide all the information necessary for precise surgical targeting.

[0039]

[0071] Optical Coherence Tomography (OCT) is a diagnostic imaging technique that can provide high-resolution images of materials and tissues. Imaging is based on reconstructing spatial information of a sample from spectral information of scattered light from 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 into spatial information along the same axis by Fourier transform. Lateral information of OCT beam propagation is typically collected by scanning the beam laterally and repeatedly performing axial probing during the scan. This method allows for the acquisition of 2D and 3D images of the sample. In time-domain OCT, the interferometer is not mechanically scanned, and interference from a wide range of light spectra is recorded simultaneously, resulting in faster image acquisition. 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 sweep-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 a sufficiently wide bandwidth of 100 nanometers (nm) or more. In spectral-domain OCT, spectral interference patterns are simultaneously recorded to a multi-channel detector such as a charge-coupled device (CCD) or complementary metal-oxide-semiconductor (CMOS) camera, whereas in swept-source OCT, interference patterns are recorded in continuous time steps using a fast photodetector and an electronic digitizer. While swept-source OCT has some advantage in terms of acquisition speed, both types of systems are rapidly evolving and improving, and the resolution and speed are sufficient for the purposes of the integrated surgical systems disclosed herein. Standalone OCT systems and OEM components are currently available from several vendors, including Optovue Inc. (Fremont, California), Topcon Medical Systems (Oakland, New Jersey), Carl Zeiss Meditec AG (Germany), Nidek (Aichi Prefecture), Thorlabs (Newton, New Jersey), Santec (Aichi Prefecture), and Axsun (Villasia, Massachusetts).

[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 includes, for example, a video camera, a telescope, and one or more illumination sources. The camera may be a digital camera fitted with a gonioscope lens for providing a gonioscope image of the eye. The illumination sources are positioned to optimize illumination of the object of interest, such as the iris-corneal angle of the eye, including the trabecular meshwork. The illumination sources may be LEDs or light transmitted via fiber optic cables. There are many illumination methods: a refractive ballistic method in which the light source is placed in the air and the light is refracted through an optical element to reach the trabecular meshwork; a transmissive ballistic method in which the illumination source is inserted into a pre-drilled hole or feature inside a lens and bonded using epoxy with a matching refractive index; or a reflective method in which light from the illumination source is reflected by a designed reflective surface of the lens near the eye before striking the trabecular meshwork.

[0042]

[0075] Access to the iris and cornea

[0076] Referring to Figures 6, 7, 8, and 13a, a feature provided by the integrated surgical system 1000 disclosed herein is the ability to access target ocular tissue within the iris-corneal angle 13 by different rays along different noncollinear optical paths 30, 31. In some embodiments, the iris-corneal 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 the aqueous humor 8 in the anterior chamber 7, while one or more other beams can access the iris-corneal 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 iris-corneal angle 13 of the eye. For example, one or more laser beams and visual observation beams access the iris-corneal angle 13 of the eye along the first optical path 30, while an OCT beam accesses the iris-corneal angle 13 of the eye along the second optical path 31. The first optical path 30 is at an angle with respect to the optical axis 24 of the eye, 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. Substantially parallel means that the degree of parallelism is within 20 degrees.

[0043]

[0077] Referring to Figure 13a, the optical system 1010 disclosed herein is configured to direct a first optical beam, such as a laser beam 201, to the iris-corneal angle 13 of the eye along an angled optical path 30 (shown in Figure 6), while directing a second optical beam, such as an OCT beam 301, to the iris-corneal angle 13 along a parallel optical path 31 (shown in Figure 6). The optical system 1010 includes a first optical subsystem 1001 and a second optical subsystem 1002.

[0044]

[0078] Continuing from Figure 13a, the first optical subsystem 1001 includes an exit lens 710, a prism 752, and a window 801. The exit lens 710 (also called a superdome) has an opposite input side and an output side. The input side of the exit lens 710 is defined by a convex surface, and the output side is defined by a concave surface. The input side of the exit lens 710 is positioned to receive a first optical beam, such as a laser beam. The prism 752 has a flat input surface positioned to receive a second optical beam, such as an OCT beam, and an output surface configured to connect with a portion of the convex surface of the exit lens 710.

[0045]

[0079] Window 801 has an input side and an output side on opposite sides. The input side of window 801 is defined by a convex surface, and the output side is defined by a concave surface. The concave surface of window 801 is connected to the convex surface of the exit lens 710 to define a first optical axis 705 (hereinafter also referred to herein simply as the “axis”, the “first optical subsystem axis”, or simply the “subsystem axis”) passing through the window and the exit lens. The concave surface of window 801 is configured to be detachably connected to the cornea 3 of eye 1, and when connected to the eye, the first optical axis is approximately aligned with the line of sight of the eye or the optical axis 24 of the eye.

[0046]

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

[0047]

[0081] With respect to the first light beam, the optical system 1010 is configured such that the first light beam, for example, a laser beam 201 and / or a visual observation beam 401, is directed to enter 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 refractive indices of the exit lens 710 and the window 801 are configured to compensate for the refraction and distortion of the light ray by bending the light beam, thereby directing it through the cornea 3 of the eye to the iris-corneal angle 13. More specifically, the first optical subsystem 1001 bends the beam so that the first light beam, for example, a laser beam 201, exits the first optical subsystem and enters the cornea 3 at an appropriate angle, thereby causing the beam to pass through the cornea and the aqueous humor 8 of the anterior chamber 7 and travel along the angled optical path 30 toward the iris-corneal angle 13.

[0048]

[0082] Referring to Figure 6, accessing the iris-corneal angle 13 along an angled optical path 30 offers several advantages. The advantage of this angled optical path 30 to the iris-corneal angle 13 is that the light beam passes through mostly transparent tissues such as the cornea 3 and aqueous humor 8 in the anterior chamber 7. Therefore, beam scattering by tissue is not significant. This is beneficial when the light beam is a laser beam or a visual observation light beam. A further advantage of the angled optical path 30 to the iris-corneal angle 13 through the cornea 3 and anterior chamber 7 is that it avoids the laser beam directly illuminating the retina 11. As a result, higher average power laser light can be used for imaging and surgery, which consequently leads to faster surgery and reduced tissue movement during surgery.

[0049]

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

[0050]

[0084] As mentioned above, several advantages are obtained by providing OCT beam access to the iris-corneal angle 13 along a parallel optical path 31 separate from the angled optical path 30 of the laser beam. For example, the parallel optical path 31 of the OCT beam avoids any laser treatment byproducts that may be present in the region of the angled optical path 30. The parallel optical path 31 also avoids optical aberrations and absorptions at ocular tissue interfaces, such as the interface between the cornea and aqueous humor, and the interface between the aqueous humor and the trabecular meshwork. The following optical aberrations and absorptions are avoided: 1) providing higher OCT resolution and contrast, and higher sensitivity; 2) allowing the OCT beam to penetrate deeply into the tissue and fully display the vicinity of Schlemm's canal and the collector channel; and 3) enabling the use of lower OCT beam power and different wavelengths for OCT.

[0051]

[0085] By providing OCT beam access to the iris-corneal angle 13 along the parallel optical path 31, it is possible to access various peripheral corneal tissues for laser treatment, as well as identify and target these tissues, separately from the angled optical path 30 of the laser beam. For example, this enables imaging and targeted treatment of not only the trabecular meshwork, but also Schlemm's canal, collecting duct, aqueous vein, and scleral tissue. Providing OCT beam access to the iris-corneal angle 13 along the parallel optical path 31 also provides the ability to image tissue during and immediately after surgical laser treatment, separately 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 iris-corneal angle 13 along the parallel optical path 31 also allows for obtaining images suitable for pre-operative treatment planning. Separating the OCT optical path from the laser optical path allows for optimization of each beam, reducing aberrations and wavelength dispersion, and enabling independent polarization adjustment.

[0052]

[0086] We have outlined the Integrated Surgical System 1000 and some of its features and advantages; now, we will describe the system and its components in more detail.

[0053]

[0087] Integrated surgical system

[0088] Referring to Figure 7, the integrated surgical system 1000 for non-invasive glaucoma surgery includes a control system 100, surgical components 200, a first imaging component 300, and an optional second imaging component 400. In the embodiment of Figure 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 to the system. The visual observation device 400, together with the OCT imaging device 300, provides images that help 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 lens 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 other components of the integrated surgical system 1000. The user interface 110 of the control system 100 accepts instructions from the user and displays information for the user to observe. User input information and commands include, but are not limited to, system commands, motion controls for docking the patient's eye 1 to the system 1000, selection of a pre-programmed or live-generated surgical plan, determination of the surgical site based on images of the eye, including visual observations and OCT images, navigation of menu selections, setting of surgical parameters, responding to system messages, determination and approval of the surgical plan, and commands for executing the surgical plan. Output from the system to the user includes, but are not limited to, displays of system parameters and messages, displays of images of the eye, including visual observations and OCT images, and graphics, numerical, and text displays of the surgical plan and surgical progress.

[0055]

[0090] The control system 100 is connected to 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 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, as well as the acquisition, analysis, and display of OCT images. Control signals to the laser scanning system may include the position, size, and shape of the surgical pattern, expressed in the position coordinates of the planned position of the laser focal point and the scanning path of the laser across the entire surgical volume. These types of control signals can be pre-programmed, and the operator can select one or more control parameters. Control parameters of the surgical pattern may include the position of the laser pulse pattern, the shape, length, width, depth, laser spot, line-to-layer separation, and energy. Before operating the surgical system, control signals between various subsystems and components are coordinated. Calibration includes calibrating the pixel coordinates acquired and displayed by the visual observation device 400 and the OCT imaging device 300 to the actual physical coordinates within the eye, and calibrating the commanded operation of the OCT and laser scanner systems to match the actual displacement of the OCT and laser beams within the eye.

[0056]

[0091] Instructing the integrated surgical system 1000 to perform a surgical incision includes docking the system to the eye, acquiring and displaying visual observation images and OCT images on a computer screen, determining the coordinate position 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 collected from these images. The image-based parameters may be determined by the operator of the integrated surgical system 1000 or by image processing and analysis computer algorithms. Instructions using these parameters can be given by the operator as input data in text format, 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 a scanning mirror, for scanning the laser beam 201 and the OCT beam 301 independently of each other. Various types of scanners can be used for scanning the laser beam 201 and the OCT beam 301. For scanning laterally to the beams 201 and 301, angular scanning galvanometer scanners are available, for example, from Cambridge Technology in Bedford, Massachusetts, and Scanlab in Munich, Germany. To optimize the scanning speed, the scanning mirror is usually set to the smallest size that can support the required scanning angle and numerical aperture of the beam at the target position. The ideal beam size in the scanner is usually different from the beam size of the laser beam 201 or the OCT beam 301, and also different from what is required at the entrance of the focusing objective lens head 700. Therefore, beam conditioners are applied before, after, or between individual scanners. The beam conditioner and scanner 500 include scanners for scanning the beam laterally and axially. Axial scanning changes the depth of focus in the area of ​​interest. Axial scanning can be performed by moving a lens axially within the beam path using a servo motor or stepping motor.

[0058]

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

[0059]

[0094] To resolve the ocular tissue structure of the eye in sufficient detail, the imaging components 300 and 400 of the integrated surgical system 1000 can provide an OCT beam 301 and a visual observation beam 401 having a spatial resolution of several micrometers. The resolution of the OCT beam 301 is the spatial dimension of the smallest feature recognizable in the OCT image. This is mainly determined by the wavelength and spectral bandwidth of the OCT source, the quality of the optical system that delivers the OCT beam 301 to the target site in 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 transmitted to the target location with an accuracy of a few micrometers. The resolution of the laser beam 201 is the spatial dimension of the smallest feature of the target location that can be altered by the laser beam without significantly affecting the surrounding ocular tissue. This is mainly determined by the wavelength of the laser beam 201, the quality of the optical system that transmits the laser beam to the target location in 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 threshold energy for photodestructive interaction, the size of the laser spot needs to be approximately 5 μm or less.

[0061]

[0096] The visual observation beam 401 is acquired by the visual observation device 400 using a fixed, non-scanning optical system, but it should be noted that the OCT beam 301 of the OCT imaging device 300 is scanned transversely 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 actual embodiments, the combination of beam conditioning, scanning, and optical path is a specific function performed on laser, OCT, and visual observation light beams. The implementation of these functions may also be performed in an order different from that shown in Figure 7. The specific optical hardware that manipulates the beams to perform these functions can have multiple arrangements in terms of how the optical hardware is positioned. These can be arranged to manipulate individual light beams separately, and in another embodiment, one component can combine functions to manipulate different beams. In embodiments disclosed herein, the beam conditioner and scanner 500 includes two sets of scanners: one for scanning the laser beam 201 and another for scanning the OCT beam 301. The individual beam conditioners within the beam conditioner and scanner 500 set the respective beam parameters of the laser beam 201 and the OCT beam 301. Various combinations of optical hardware devices are possible in the integrated surgical system, but the following sections detail an example device.

[0063]

[0098] Beam transmission

[0099] In the following description, the term “beam” may refer to a laser beam, OCT beam, illumination beam, or visual observation beam, depending on the context. The term “collinear beam” refers to two or more different beams combined by the optics of the Integrated Surgical System 1000 that share the same path to the same target location in the eye upon entering the eye. The term “non-collinear beam” refers to two or more different beams that have different paths to the eye. The term “co-targeted beam” refers to two or more different beams that have different paths to the eye but target the same location in the eye. In collinear beams, 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 multiplexing of the different beams. In non-collinear beams, different beams are transmitted to the eye along different optical paths separated spatially or by the angle between the beams. In the following description, either the aforementioned beams or composite beams may be collectively referred to as optical beams. The terms “distal” and “proximal” may be used to specify the direction of beam movement or the physical location between components within the Integrated Surgical System. The distal direction refers to the direction toward the eye; therefore, the OCT beam output by the OCT imaging device moves distally toward the eye. The proximal direction refers to the direction toward the eye; therefore, the OCT return beam from the eye moves proximally toward the OCT imaging device.

[0064]

[0100] Referring to Figure 8, according to embodiments disclosed herein, the integrated surgical system is configured to transmit the laser beam 201, the OCT beam 301, and the visual observation beam 401 distally toward the eye 1, and to receive the OCT return beam and the 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 an angled optical path to a region of the eye 1 including the surgical volume 720, and the OCT beam 301 is transmitted along a second optical path or a parallel optical path to the same region of the eye. Thus, the laser beam 201 and the OCT beam 301 are both targeted noncollinear beams.

[0065]

[0101] Regarding visual observation, the visual observation beam 401 directed towards the eye is a light beam from the illumination source of the visual observation device, and the visual observation return beam returning from 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 the beam conditioner 510, where basic beam parameters, beam size, and divergence are set. The beam conditioner 510 can also perform additional functions such as setting beam power or pulse energy and turning the beam on or off by shutter. After passing through the beam conditioner 510, the laser beam 210 enters the axial scanning lens 520. The axial scanning lens 520 includes a single lens or a group of lenses and is movable axially oriented 522 by a servo motor, stepping motor, or other control mechanism. The movement of the axial scanning lens 520 axially oriented 522 changes the axial distance of the focal point of the laser beam 210 at the focal point.

[0067]

[0103] The intermediate focus 722 is set to fall within a conjugate surgical volume 721, which is the image conjugate of the surgical volume 720 determined by the focusing objective head 700, and is scannable within it. The surgical volume 720 is the spatial range 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 the vicinity of the iris-corneal angle 13 of the eye. A pair of lateral scanning mirrors 530, 532, rotated by the galvanometer scanner, scan 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-connecting mirror 602 configured to connect the laser beam 201 with the visual observation beam 401.

[0068]

[0104] The composite laser / visible light 201 / 401 moving distally then passes through a focusing lens 750 contained in the focusing objective head 700, is reflected by a reflective surface 740, which is a planar beam folding mirror or a facet in the optical system, and then passes through the exit lens 710 of the focusing objective lens head 700 and the window 801 of the patient interface, where the intermediate focal point 722 of the laser beam in the conjugate surgical volume 721 is re-imaged to a focal point in the surgical volume 720. The focusing objective head 700 re-images the intermediate focal point 722 to the ocular tissue in the surgical volume 720 via the window 801 of the patient interface. In one configuration, the facet-shaped reflective surface 740 inside the optical component has a coating specialized for broadband reflection (visible light, OCT, femtosecond), resulting in a small difference in group delay dispersion (GDD) between s-polarization and p-polarization.

[0069]

[0105] Regarding OCT beam transmission, the OCT beam 301 output by the OCT imaging device 300 passes through a lateral scanner equipped with a beam conditioner 511, an axially movable focusing lens 521, and scanning mirrors 531, 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 obtain 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 reconjugated by the interferometer. However, if the surgical volume 720 is divided into multiple axial segments, the focusing lens 521 can be used to readjust the focus. 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 multiple ranges.

[0070]

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

[0071]

[0107] The scattered OCT return beam 301 from the ocular tissue travels proximal and returns to the OCT imaging device 300 in the reverse order along the same path described earlier. The reference beam 302 of the OCT imaging device 300 passes through the reference delay path and returns to the OCT imaging device via the movable mirror 330. The reference beam 302 is interferometrically coupled with the OCT return beam 301 as it returns within the OCT imaging device 300. The delay amount of 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 obtain the best axial OCT resolution, the OCT return beam 301 and the reference beam 302 are also dispersion-compensated, and the group velocity dispersion in the two arms of the OCT interferometer is equalized.

[0072]

[0108] As the laser beam 201 passes through the cornea 3 and anterior chamber 7, the beam passes over the posterior and anterior surfaces of the cornea at a steep angle, significantly different from the normal entry angle. These surfaces in the path of the laser beam 201 generate excessive astigmatism and coma aberration that need to be compensated for.

[0073]

[0109] Referring to Figures 9a and 9b, in an embodiment of the integrated surgical system 1000, the optical components of the focusing objective lens 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 iris-corneal angle 13 of the eye, and another parallel optical path through the cornea, avoiding the anterior chamber and the aqueous humor of the anterior chamber, to the iris-corneal angle of the eye. The parallel optical path is substantially parallel to the first optical subsystem axis 705 of the first optical subsystem 1001. The first optical subsystem axis 705 substantially coincides with the optical axis 24 of the eye when the first optical subsystem 1001 is connected to the eye. Thus, the parallel optical path is also substantially parallel to the optical axis 24 of the eye. Substantially parallel means 20 degrees of parallelism.

[0074]

[0110] Figure 9a shows the eye 1, patient interface 800, and focusing objective lens head 700 connected together. Figure 9b shows the eye 1, patient interface 800, and focusing objective lens head 700 separated from each other. In Figures 9a and 9b, for the sake of simplicity, the reflective surface 742 of Figure 8 is not shown, and the path of the OCT beam 301 is shown in an unfolded manner.

[0075]

[0111] The patient interface 800 optically and physically connects eye 1 to the focusing objective lens head 700, and the focusing objective lens head 700 optically connects to other components of the integrated surgical system 1000. The patient interface 800 provides multiple functions: fixing the eye to the components of the integrated surgical system, creating a sterile barrier between the components and the patient, and providing optical access between the eye and the components. The patient interface 800 is a sterile, disposable device and is detachably connected to eye 1 and the focusing objective lens head 700 of the integrated surgical system 1000.

[0076]

[0112] Referring to Figures 9a, 9b, 9c, and 13a, the patient interface 800 includes a window 801 which is part of the first optical subsystem 1001. The window 801 has a concave surface 812 facing the eye and a convex surface 813 facing the objective lens on the opposite side of the concave surface. Thus, the window 801 has a meniscus shape. The concave surface 812 has a radius of curvature r e Characterized by the fact that the convex surface 813 has a radius of curvature r w Characterized by the following: The concave surface 812 is configured to connect to the eye either in direct contact or via a refractive index matching material, liquid, or gel 807 placed between the concave surface 812 and the eye 1. The window 801 can be formed of a solid material, with a refractive index n w It has. In one embodiment, the window 801 is formed of fused silica, and the refractive index n w The refractive index is 1.45. Fused silica has the lowest refractive index among common, inexpensive glasses. Fluoropolymers such as Teflon AF are another class of low refractive index materials with a refractive index even 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 of common glass BK7, with a refractive index n w The value is 1.50. Using BK7G18 from Schott AG in Mainz, Germany, a radiation-resistant version of this glass, gamma sterilization of the patient interface 800 is possible without the optical properties of the window 801 being altered by gamma rays.

[0077]

[0113] As shown in Figures 9a and 9b, the window 801 is surrounded by the wall 803 of the patient interface 800 and a fixing device such as a suction ring 804. When the suction ring 804 contacts the eye 1, an annular cavity 805 is formed between the suction ring and the eye. When a vacuum is applied to the 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 the suction ring attaches the eye to the patient interface 800 during surgery. When the vacuum is released, the 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 lens 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 by mechanical, vacuum, magnetic, or other principles and is also detachable from the integrated surgical system. In this configuration, the focusing objective lens head 700 is fixed to the patient interface 800, and the patient interface 800 is fixed to the eye. In other configurations described later, an additional component is included between the focusing objective lens head 700 and the patient interface 800. The additional component is fixed to the patient interface 800 but not to the focusing objective lens head 700. Instead, the focusing objective lens head 700 can rotate within the additional component without rotational torque being transmitted to the patient interface 800 fixed to the eye.

[0079]

[0115] Referring to Figures 9a, 9b, and 9c, the focusing objective lens head 700 includes an exit lens 710 and a prism 752, which are part of the first optical subsystem 1001. In the configurations shown in these figures, the exit lens 710 is aspherical and includes a concave surface 711 and a generally convex surface 712 opposite the concave surface, and the prism 752 includes an input or entry surface 753 and an output or exit surface 755. The generally convex surface 712 of the exit lens 710 includes a modified front surface 719 configured to connect to the exit surface 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 surface 755 of the prism 752. The shape is, 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, with a refractive index n xIt is 1.45. Prism 752 is made of fused silica and has the same refractive index n as the exit lens 710. p It holds.

[0080]

[0116] Referring to Figure 9c, the concave surface 711 has a radius of curvature r. y Characterized by the aspherical shape, the convex surface 712 is characterized by its aspherical shape. By combining the aspherical convex surface 712 and the spherical concave surface 711, an exit lens 710 with varying thickness is obtained, where the outer edge 715 of the lens is thinner than the central vertex region 717 of the lens. The concave surface 711 is configured to connect to the convex surface 813 of the window 801.

[0081]

[0117] Referring to Figures 10a, 10b, 10c, and 10d, alternative configurations of the first optical subsystem 1001 are considered, each of which can be used in place of the first optical subsystem in Figures 9a-9c. In each of these configurations, the optical components of the focusing objective lens head 700 are structured and positioned relative to the window 801 of the patient interface 800, providing laser beam path and OCT beam path functions similar to those in the configurations of Figures 9a-9c. In Figures 10a, 10b, 10c, and 10d, respectively, the exit lenses 710a, 710b, 710c, and 710d include reflective surfaces 740 that reflect the laser beam 201 and coincide with the laser axes 706a, 706b, 706c, and 706d that extend into the iris-corneal 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 the exit lens 710d along the OCT axis 707a extending into the iris-corneal angle of the eye. In Figure 10b, prism 752b is configured to direct the OCT beam 301 to the exit lens 710b along the OCT axis 707b extending into the iris-corneal angle of the eye. In Figures 10c and 10d, each of the prisms 752c and 752d has one or more reflective surfaces and the OCT beam 301 is reflected into the exit lenses 710c and 710d along the OCT axes 707c and 707d extending into the iris-corneal angle of the eye. Comparing the OCT axes in Figures 10a to 10d, the OCT axis 707a in Figure 10a is closer to parallel with the subsystem axis 705 than the OCT axes 707b, 707c, and 707d in Figures 10b to 10d.

[0083]

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

[0084]

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

[0085]

[0121] Figure 13a is a schematic diagram of the components of the integrated surgical system 1000 of Figures 7 and 8, which are functionally arranged to form an optical system 1010 having a first optical subsystem 1001 and a second optical subsystem 1002, enabling multipath access to a common surgical volume 720 of the iris-corneal angle 13, and the multipath access includes 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 OCT beam 301 passing through the first optical subsystem of Figure 13a.

[0086]

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

[0087]

[0123] Those skilled in the art will understand that adding or removing a planar beam folding mirror or other types of reflective surfaces does not change the main operation of the optical system 1010 formed by the first optical subsystem 1001 and the second optical subsystem 1002. It will also be understood that the configuration of the optical components, such as the exit lens 710 and prism 752 of the focusing objective lens head 700, is essentially schematic, and that numerous other configurations are conceivable, as previously mentioned with reference to Figures 10a, 10b, 10c, and 10d.

[0088]

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

[0089]

[0125] During surgery, the first optical subsystem 1001 is assembled by connecting the convex surface 813 of the window 801 to the concave surface 711 of the exit lens 710. For this purpose, 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 connected to the convex surface 813 of the window 801. Referring to FIG. 9b, the connection may be made by direct contact between the exit lens 710 and the window 801, or may be made by indirect contact through a layer of refractive index matching fluid. For example, when docking the patient interface 800 to the focusing objective lens head 700, a drop of refractive index matching fluid or gel 807 is applied between the contact surfaces to eliminate any possible air gaps between the two surfaces 711, 813, and to help the laser beam 201 and the OCT beam 301 pass through the gap while minimizing Fresnel reflection and distortion. Referring to FIG. 11a, the connection between the exit lens 710 and the window 801 can be made by indirect contact through the transparent window 811 of the interface structure 810a. Referring to FIG. 12a, the connection between the exit lens 710 and the window 801 can be made by indirect contact through a layer of refractive index matching fluid or gel 807 within the aperture 814 of the 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. For this purpose, referring to FIG. 13b, the refractive index n x of the exit lens 710 and the refractive index n w of the window 801 are selected taking into account the refractive index n c of the cornea 3, causing appropriate bending of the beam through the first subsystem 1001 so that the optical path is generally adjusted to fit within the iridocorneal angle 13 when the beam 701 exits the subsystem and passes through the cornea 3.

[0091]

[0127] Referring to Figure 13b, we begin with the interface between the window 801 and the cornea 3. If the entry 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 may 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 approximately match the refractive index of the cornea 3.

[0092]

[0128] Excessive refraction and distortion at the interface where the laser beam 201 exits window 801 and enters the cornea 3 can be further corrected by controlling the bending of the beam 701 as it passes through the exit lens 710 and window 801. For this reason, in one embodiment of the first optical subsystem 1001, the refractive index n of window 801 w The refractive index n of the output lens 710 x and the refractive index n of the cornea 3 c Each of these is greater than the others. As a result, at the interface where the laser beam 201 exits the exit lens 710 and enters the window 801, that is, the interface between the concave surface 711 of the exit lens and the convex surface 813 of the window, the beam passes through a change from a high refractive index to a low refractive index, and the beam bends in a first direction. Next, at the interface where the laser beam 201 exits the window 801 and enters the cornea 3, for example, at the interface between the concave surface 812 of the exit lens and the convex surface of the cornea, the beam passes through a change from a low refractive index to a high refractive index, and as a result, the beam bends in a second direction opposite to the first direction.

[0093]

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

[0094]

[0130] While directing the OCT beam 301 through the cornea to the surgical volume 720 at the iris-corneal angle 13 of the eye, the prism 752 of the first optical subsystem 1001 receives the OCT beam 301 moving along the input axis 707i through the input surface 753, so as to avoid the anterior chamber, and directs the OCT beam 301 along the output axis 707o which is parallel or nearly parallel to the optical axis 24 of the eye, thereby positioning and designing the OCT beam to focus on the surgical volume 720, such as the trabecular meshwork. The entry angle of the OCT beam 301 to the entry 753 is in the range of 0 to 10 degrees.

[0095]

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

[0096]

[0132] The position of the centroid 799 of the prism relative to the optical axis 24 of the eye also contributes to the focal position. If the prism 752 is eccentric along an axis perpendicular to the optical axis 24, this corresponds to the focal point on the image plane being eccentric along the same perpendicular axis. The exit lens 710 is modified to ensure the precise spatial placement of the prism 752 is within an acceptable level of eccentricity. The modification can consist of any machined features, such as a flat modification surface 719 that can be registered relative to the prism 752 during the process of bonding the prism to the exit lens 710, as described above with reference to Figure 9c. The permanent physical connection between the prism 752 and the exit lens 710 is achieved using optical-grade epoxy with matching refractive indices.

[0097]

[0133] To prevent aberrations, the entry angle between the prism entry surface 753 and the input axis 707i is generally between 0 and 10 degrees. The prism 752 is connected to the exit lens 710 and precisely positioned in space by machining features into the exit lens so that the exit surface 755 matches the modified surface 719 of the exit lens 710.

[0098]

[0134] Referring to Figure 10e, the curved upper surface 712e of the exit lens 710e results in a high entry angle and a steep refraction angle for the input OCT beam along the OCT input axis 707i, if the prism 752e is absent. Given the extremely limited space within the focusing objective lens head 700, it can be geometrically difficult to angle and direct the OCT beam 301 relative to the curved upper surface 712e of the exit lens 710e so that the OCT beam strikes the surgical volume 720. To address this, the prism 752e in Figure 10e has three surfaces: an entry surface 753e, a reflection surface 757e, and an exit surface 755e. Prism 752e is mechanically positioned and designed so that the nominal entry angle of the OCT beam 301 at the inlet surface 753e is perpendicular, and the deviation of the OCT beam scanner is minimal (+ / -10 degrees), thereby minimizing the refraction and aberration of the scanned beam. Several other design measures have been taken to minimize changes in the refraction angle. Firstly, prism 752e is made of the same material as the exit lens 710e. Secondly, the area of ​​the upper surface 712e is modified to have an angled plane that is machined for the positioning and registration of the prism to connect the prism to the exit lens 710e. The modified surface 719e includes an angled plane parallel to the exit surface 755e of prism 752e. Since the exit surface 755e and the modified surface 719e of prism 752e are parallel, and the prism and exit lens 710e are made of the same material, no refraction occurs when the OCT beam 301 passes through the interface between the prism and the lens.

[0099]

[0135] Referring to Figure 13a, the first optical subsystem 1001 includes a subsystem axis 705 that substantially coincides with the optical axis 24 of the eye when the focusing objective head 700 and the 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 therefore the optical axis 24) by a distance such that the OCT beam 301 avoids the anterior chamber 7 of the eye.

[0100]

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

[0101]

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

[0102]

[0138] Furthermore, referring to Figures 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 lens 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 previously mentioned, in the embodiments of Figures 11 and 12b, the focusing objective lens head 700 is configured to rotate relative to the fixed patient interface 800. Referring further to Figure 13a, when the focusing objective lens head 700 is rotated, the laser beam 201 and laser axis 706 provided by the second optical subsystem 1002 rotate together relative to the fixed window 801 and around the subsystem axis 705. Similarly, the OCT beam 301 and OCT axis 707 provided by the second optical subsystem 1002 rotate together with respect to a fixed window 801 and around subsystem axis 705. This allows the laser beam 201 and OCT beam 301 to provide optical access to the entire 360-degree periphery of the iris-corneal angle 13 of eye 1, while preserving the angle α between subsystem axis 705 and laser axis 706, the angle δ between laser axis 706 and OCT axis 707, and the offset between the first optical subsystem axis 705 and OCT axis 707.

[0103]

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

[0104]

[0140] Table 1 TIFF2026108657000002.tif74170

[0105]

[0141] In this design, numerical apertures (NAs) of up to 0.2 generate diffraction-limited focuses for a 1030 nm wavelength laser beam and an 850 nm wavelength OCT beam. In one design, optical anomalies in the first optical subsystem are compensated to such an extent that the Strehl ratio of the first optical subsystem for beams with numerical apertures greater than 0.15 at iris-corneal angles exceeds 0.9. In another design, optical anomalies in the first optical subsystem are partially compensated, and the remaining uncompensated anomalies in the first optical system are compensated by the second optical subsystem, so that the Strehl ratio of the first and second optical subsystems for beams with numerical apertures greater than 0.15 at iris-corneal angles exceeds 0.9.

[0106]

[0142] Referring to Figures 8 to 13B, a focused focusing objective lens head 700 configured to connect to a patient interface 800 is disclosed. The patient interface 800 includes a window 801 configured to connect to the cornea of ​​eye 1. The focusing objective lens head 700 includes an exit lens 710 and a prism 752 mechanically and optically coupled to the exit lens. The exit lens 710 and the prism 752 together form an optical assembly mechanically fixed to the housing 702 of the focusing objective lens head 700. The exit lens 710 is optically coupled to the window 801 of the patient interface 800 and configured to align the axis 705 of the exit lens with the optical axis 24 of eye 1. Referring to Figure 13a, the optical assembly formed by the exit lens 710 and the prism 752 is configured to receive the OCT beam 301 incident at the entry surface 753 of the prism along the OCT input axis 707i and to direct the OCT beam to the OCT output axis 707o. The OCT output axis 707o is substantially parallel to the axis 705 of the exit lens 710, radially offset from the axis of the exit lens, extends through the exit lens to the cornea, and extends to the iris-corneal angle 13 of 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 entry surface 712 of the exit lens 710 along the laser input axis 706i and direct the laser beam along an angled optical path 706 (also referred herein as the “laser optical path” or “laser axis”), through the exit lens, through the cornea, through the anterior chamber 7, into a target volume 720 of ocular tissue within the iris-corneal angle 13. For this purpose, 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] Referring to Figures 9a and 9b, in some embodiments, the housing 702 of the focusing objective lens head 700 is configured to connect directly to the patient interface 800. Referring to Figures 11a, 11b, 12a, and 12b, in some embodiments, the housing 702 of the focusing objective lens head 700 is configured to connect indirectly to the patient interface 800 via interface structures 810a, 810b, which are configured to mechanically connect the housing to the patient interface. In these embodiments, the housing 702 of the focusing objective lens head 700 is configured to rotate within the interface structures 810a, 810b, thereby rotating the optical assembly formed by the exit lens 710 and the prism 752 around the axis 705 of the exit lens 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] Referring to Figures 8, 10e, and 13a, the focusing objective lens head 700 may be fixed to the housing 702 and positioned relative to the optical assembly formed by the exit lens 710 and the prism 752, and may include directing the OCT beam 301 incident along the OCT input axis 707i to the entry surface 753 of the prism 752. The focusing objective lens head 700 may further include an OCT focusing lens 751 (shown in Figures 8 and 13a) mechanically fixed to the housing 702, which receives the OCT beam 301 from the OCT imaging device 300 and is positioned relative to the OCT mirror 742 (shown in Figure 8) to direct the OCT beam to the OCT mirror. The focusing objective lens head 700 is mechanically fixed to the housing 702 and may further include a laser focusing lens 750 positioned relative to the optical assembly formed by the exit lens 710 and the prism 752, which receives the laser beam 201 and directs the laser beam toward the entry surface 712 of the exit lens. The focusing objective lens head 700 may also include a laser scanner 500 (shown in Figure 13a) fixed to the housing 702 and positioned between the laser source 200 and the laser focusing lens 750, and optically coupled.

[0109]

[0145] Details of the mechanical connection between the laser focusing lens 750, the OCT focusing lens 751, the OCT mirror 742, and the laser scanner 500 and the housing 702 are not shown, but 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 the prism 752.

[0110]

[0146] minimally invasive surgical treatment

[0147] Figure 14 is a three-dimensional schematic diagram of the anatomical structures of the eye related to surgical treatment made possible by the integrated surgical system 1000. To reduce IOP, laser treatment targets ocular tissues that affect the trabecular meshwork outflow pathway 40. These ocular tissues include the trabecular meshwork 12, scleral spines 14, Schlemm's canal 18, and collecting canals 19. The trabecular meshwork 12 consists of three layers: the uvea 15, the corneoscleral reticular 16, and the proximal canaliculi tissue 17. These layers are porous and water-permeable, with the uvea 15 being the most porous and permeable, followed by the corneoscleral reticular 16. The least porous and least permeable layer in the trabecular meshwork 12 is the proximal canaliculi tissue 17. The inner wall 18a of Schlemm's canal 18 is also porous and water-permeable, having similar properties to the proximal canaliculi tissue 17.

[0111]

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

[0112]

[0149] In surgical treatment, the design and selection of laser treatment patterns reduce resistance to the outflow pathway and minimize alteration of ocular tissue. 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 degree of influence of the laser-tissue interaction. When laser spots, or cells, are densely arranged along a line, the laser creates a narrow, fine channel. By arranging multiple laser spots closely spaced within the cross-section of the channel, a wider channel can be created. The arrangement of cells may be similar to the arrangement of atoms in a crystal structure.

[0113]

[0150] Referring to Figure 15, the processing pattern P1 can take the form of a cubic structure containing individual cells arranged in regularly spaced rows, columns, and sheets or layers. The processing pattern P1 is characterized by x, y, and z dimensions, where the x, y, and z coordinates of the cells are calculated sequentially from adjacent cells in the order of column position (x coordinate), row position (y coordinate), and layer position (z coordinate). The 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] Treatment pattern P1 is typically defined by a series of surgical parameters. These parameters may include one or more treatment areas A, which represent surface areas or layers of ocular tissue through which the laser passes. Treatment area A is determined by the treatment height h and the lateral extent of treatment w. The treatment thickness t represents the level to which the laser cuts the ocular tissue, from the distal range or boundary of the treatment volume in or near Schlemm's canal 18 to the proximal range or boundary of the trabecular meshwork 12 surface or near it. Thus, the laser applied according to the treatment pattern may affect, generate, or affect the fluids within the ocular structure in a manner similar to a three-dimensional model of the treatment pattern.

[0115]

[0152] Additional surgical parameters define the placement of the intraocular surgical volume or the volume affected. For example, referring to Figures 14 and 15, placement parameters may include one or more of the following: position l, representing where the treatment is performed relative to the inscribed angle of the eye; and treatment depth d, representing the position of the three-dimensional model of intraocular tissue or ocular fluid relative to the reference ocular structure. Below, the treatment depth d for the region where the anterior chamber 7 is in contact with the trabecular meshwork 12 is shown and explained. Combining the treatment pattern and placement parameters defines the treatment plan.

[0116]

[0153] Femtosecond lasers provide highly localized, non-thermal, photodestructive laser-tissue interactions while minimizing collateral damage to surrounding eye tissue. In optically transparent tissues, the photodestructive interaction of the laser is utilized. The primary mechanism by which laser energy is accumulated in eye 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 are not at the focal point are unaffected by the laser. Therefore, the interaction region with eye tissue is highly localized both laterally and axially along the laser beam.

[0117]

[0154] Referring to Figures 14 and 15, the 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 to which the treatment pattern is applied may be identified. The surgical volume 900 of ocular tissue may include the trabecular meshwork 12 and a portion of Schlemm's canal 18. For example, the surgical volume 900 of ocular tissue shown in Figure 14 includes the uvea 15, the corneoscleral retina 16, the proximal 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 the laser at various depths in the ocular tissue and scans in multiple directions to affect the three-dimensional volume of the tissue, including multiple sheets or layers of the affected tissue.

[0118]

[0155] Referring to Figures 15 and 16, during the laser scanning procedure, the surgical laser beam 701 can scan the ocular tissue according to the treatment pattern P1, forming openings 902 that penetrate the anterior chamber 7, the uvea 15, the corneoscleral network 16, the tubular tissue 17 of the trabecular meshwork network 12, and the inner wall 18a of Schlemm's canal 18, respectively. Although the opening 902 illustrated in Figure 16 is depicted as a continuous single lumen defining a fluid pathway, the opening may be defined as an array of adjacent pores, or a combination thereof, forming a sponge-like structure that defines a fluid pathway. Although the opening 902 illustrated in Figure 16 is cubic in shape, the opening may have other geometric shapes.

[0119]

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

[0120]

[0157] Referring to Figures 14 and 15, the initial placement of the intraocular laser focus is defined by a set of placement parameters, including depth d and position l. Position l defines a point around the inscribed angle of the eye where laser treatment begins, and depth d defines a point between the anterior chamber 7 and Schlemm's canal 18 where laser treatment begins or ends. Depth d is measured relative to the region where the anterior chamber 7 is in contact with the trabecular meshwork 12. Thus, a first point of the trabecular meshwork 12 closer to Schlemm's canal 18 is deeper than a second point of the trabecular meshwork 12 closer to the anterior chamber 7. Alternatively, the second point may be described as shallower than the first point.

[0121]

[0158] Referring to Figure 16, the opening 902 resulting from the laser application of treatment pattern P1 is similar to the surgical volume 900 and is characterized by an area A and 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 area A defines the cross-sectional area of ​​the opening 902.

[0122]

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

[0123]

[0160] The laser focus scan used here generally corresponds to a raster-type movement of the laser focus in the x, y, and z directions. The laser focus is positioned at a single 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-directional raster scan of the laser focus defines layers of the laser scan and generates layers of tissue affected by the laser.

[0124]

[0161] During the laser scan, pulsed laser shots are irradiated onto the tissue within the volume of ocular tissue corresponding to treatment pattern P1. Because the laser interaction volume is small, on the order of a few micrometers (μm), the interaction between each repeated laser shot and the ocular tissue locally destroys the ocular tissue at the laser's focal point. The laser pulse duration for photodestructive interaction in ocular tissue ranges from a few femtoseconds to a few nanoseconds, and the pulse energy ranges 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 the tissue material and generating gas bubbles within the moist tissue. When laser pulses are irradiated in close proximity to each other along geometric lines and surfaces, the tissue is fragmented by mechanical stress from the decomposition of tissue material and bubble formation, forming clean, continuous sections.

[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 scan speed.

[0126]

[0163] Table 2 TIFF2026108657000003.tif71170

[0127]

[0164] Referring to Figures 17a and 17b, a 3D treatment pattern P1 can be defined by a number of 2D treatment layers 1702 or treatment planes stacked to form a 3D treatment pattern characterized by width w, height h, and 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 consists of an array of spots 1704 spaced apart to establish or conform to 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 called 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 called the azimuthal direction.

[0128]

[0165] Each spot 1704 within treatment pattern P1 corresponds to a location within a target volume of ocular tissue, and light energy is applied at the laser focal point to create a micro-photodestruction site. Referring to Figure 17b, each spot 1704 within treatment layer 1702 is separated from adjacent spots by programmable distances called spot separation (spot separation 1706) and line separation (line separation 1708). Treatment layer 1702 is completed with a programmed pattern width w1710 and pattern height h1712. Each layer 1702 within 3D treatment pattern P1 is separated from adjacent layers by 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 TIFF2026108657000004.tif64170

[0131]

[0168] Other, non-rectangular, and more irregular treatment patterns can also be programmed to be created within the tissue. These irregular patterns can be broken down into spots, lines, and layers, and their extent is characterized by width, height, and depth. Examples of irregular treatment patterns are described in U.S. Patent Application Publication No. 2021 / 0307964, “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 one example of 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 at various spots 1704 that define the layer by scanning the laser focus in two dimensions, e.g., width and height, or z and y, while the focus is fixed in three dimensions, e.g., depth or z, and as a treatment layer 1702 is created, the focus moves 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] Referring to Figures 18a and 18b, in a certain type of laser treatment procedure, the laser scan of the treatment layer begins at a shallow depth at the end of the treatment pattern P1 adjacent to the anterior chamber 7 and progresses layer by layer in a direction approximately corresponding to the propagation direction of the laser beam 201. More specifically, referring to Figure 18a, the laser scan of the treatment layer progresses in the z-direction toward anatomical structures such as Schlemm's canal 18, and the propagation direction of the laser beam 201 also progresses toward the same anatomical structures, e.g., Schlemm's canal 18.

[0135]

[0172] In Figure 18a, the focus of the laser beam 201 is initially located at depth d1. Depth d1 positions the laser focus in the initial layer 904 of the tissue. Once the laser focus is at the initial depth d1, the laser beam 201 is scanned in multiple directions while maintaining its focus at the initial depth. Referring 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 the visual observation device 400 of the visualization system 826 remains fixed at depth d0 while the laser beam 201 is scanning.

[0136]

[0173] Referring to Figure 18b, scanning the focus of the laser beam 201 in multiple directions causes the initial layer 904 of the tissue to be photodestroyed. Next, the focus of the laser beam 201 is moved in the z direction along the laser axis 706 to another depth d2 toward the Schlemm tube 18. This depth d2 places the laser focus in the next layer 908 of the tissue, which is deeper than the first layer 904. Once the laser focus is in the next layer 908, the focus is scanned in multiple directions while maintaining its depth.

[0137]

[0174] Returning to Figure 18b, after scanning the next layer 908, the focus of the laser beam 201 is moved further 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 are treated.

[0138]

[0175] Referring to Figures 19a and 19b, in the alternative laser treatment procedure, the laser scan of the treatment layer begins at a deep depth at the end of treatment pattern P1 adjacent to Schlemm's canal 18 and progresses layer by layer in a direction approximately opposite to the propagation direction of the laser beam 201. More specifically, referring to Figure 19a, the laser scan of the treatment layer begins at an anatomical structure, e.g., Schlemm's canal 18, and moves away from that structure toward the anterior chamber 7 in the z direction, with the propagation direction of the laser beam 201 moving toward the structure.

[0139]

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

[0140]

[0177] Referring to Figure 19b, scanning the focal point of the laser beam 201 in multiple directions causes the initial layer of tissue 910 to be photodisrupted. Next, the focal point of the laser beam 201 is moved in the z direction along the laser axis 706 toward the anterior chamber 7 to the next depth d5. The subsequent depth d5 ​​places the laser focal point in the subsequent layer of tissue 914, which is shallower than the initial layer of tissue 910. Once the laser focal point is located at the subsequent depth d5, the focal point 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 further in the z direction toward the anterior chamber 7, scanning further layers until all treatment layers 1702 of the target volume 60 of ocular tissue are treated.

[0142]

[0179] In another treatment, instead of creating a treatment pattern P1 for each treatment layer 1702 at a time, the focal point of the laser beam 201 is scanned in three dimensions. For example, while the laser focal point is moved laterally over height and / or width, e.g., in the x and / or y directions, the laser focal point vibrates axially back and forth over depth (e.g., in the z direction). The treatment pattern P1 characterized by such scanning of the laser focal point can be called a “clearing pattern”. The depth vibration of the laser focal point in the z direction occurs simultaneously with the lateral movement of the laser focal point 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] Referring to Figure 20, a method for imaging and treating an eye 1 having an optical axis 24, cornea 3, anterior chamber 7, and iris-corneal angle 13 is disclosed. This method includes imaging and laser treatment of one or more surgical or target volumes of ocular tissue around the inscribed angle 13 of eye 1, and may be performed by an integrated surgical system 1000 of Figures 8-9b having a first optical subsystem 1001 such as one of those shown in Figures 9c-10d. Referring to Figures 13a and 13b, the first optical subsystem 1001 is configured to be connected to eye 1 and includes a first optical subsystem axis 705 that is substantially aligned with the optical axis 24 of eye 1 when the first optical subsystem is connected to the eye. Substantially aligned means that the first optical subsystem axis 705 is aligned with the optical axis 24 of eye 1 within 0-5 degrees.

[0144]

[0181] In block 2002, with further reference to Figures 8 and 13b, the OCT beam 301 of the OCT imaging apparatus 300 is delivered along the OCT optical path 707 (also referred to herein as the “OCT axis”), enters the first optical subsystem 1001 along the OCT input axis 707i, and exits the first optical subsystem along the OCT output axis 707o. The OCT output axis 707o is substantially parallel to the optical axis 24 of eye 1, radially offset from the optical axis, passes through the cornea 3, and extends to a portion of the iris-corneal angle 13 at a point along the inscribed angle of the eye. The surgical volume 720, also referred herein as the target volume of ocular tissue, is contained within the portion of the iris-corneal angle 13. The OCT output axis 707o is radially offset from the optical axis 24 of 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 and anterior and posterior curvature radii. The OCT focusing lens 751 (for example, having a focal length of approximately 75 mm) included in the focusing objective lens head 700 is mounted on a linear stage. The movement of the linear stage adjusts the focal position of the OCT beam 301, taking into account the change in distance. This distance can be calculated if the patient's biometric measurements are known.

[0145]

[0182] Referring to Figure 13b, the OCT beam 301 is transmitted by receiving the OCT beam incident on the entry surface 753 of the first optical subsystem 1001 along the OCT input axis 707i and directing the OCT beam through the first optical subsystem 1001 to the OCT output axis 707o. In some embodiments, the entry surface 753 is substantially flat and is the surface of the prism 752 of the first optical subsystem 1001. In some embodiments of the first optical subsystem 1001, as shown in Figures 9c, 10a, 10b, and 13b, 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 to the OCT output axis 707o through the first optical subsystem. In another embodiment of the first optical subsystem 1001, as shown in Figures 10c and 10d, the OCT beam 301 is directed toward 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 of the iris-corneal angle 13 by aligning the OCT output axis 707o of the OCT optical path with a portion of the iris-corneal angle. For example, referring to Figures 11a and 12a, one or more optical systems of the first optical subsystem 1001 can be rotated around the subsystem axis 705 to align the OCT output axis 707o of the OCT optical path 707 with a portion of the iris-corneal angle 13. For this purpose, one or more optical systems of the first optical subsystem 1001 include a window 801 connected to the cornea 3, an exit lens 710 having a surface 711 connected to the window, and a prism 752 connected to the exit lens, the exit lens and prism rotating around 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 iris-corneal angle 13 is imaged by the OCT beam 301. For this purpose, referring further to Figure 21, the OCT imaging device 300 of the integrated surgical system 1000 is configured to acquire either a tangential (or circumferential) scan of the portion of the iris-corneal angle 13 or a radial scan of that portion, or both. 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 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 iris-corneal angle 13 containing a target volume 720 of ocular tissue. Referring to Figure 13a, the angled optical path 706 and subsystem axis 705 are angularly offset from each other so as to intersect in the anterior chamber 7 of eye 1, and the OCT optical path 707 and angled optical path 706 are angularly offset from each other so as to intersect or intersect in the iris-corneal angle 13 of eye 1. Referring to Figure 13b, the laser beam 201 is received by the entry surface 712 of the first optical subsystem 1001 along the laser force axis 706i, and is transmitted along the angled optical path 706 into the portion of the iris-corneal angle 13 by directing the laser beam through the optical system of the first optical subsystem, e.g., the exit lens 710 and window 801, and through the cornea 3 to the laser output axis 706o. In some embodiments, the entry surface 712 is curved and is the surface of the exit lens 710 of the first optical subsystem 1001.

[0149]

[0186] In some embodiments, the laser beam 201 is transmitted along the laser path 706 into the portion of the iris-corneal angle 13 having a surgical volume 720 by aligning the laser output axis 706o of the laser path to a portion of the iris-corneal angle. For example, referring to Figures 11a and 12a, one or more optical systems of the first optical subsystem 1001 can be rotated around the subsystem axis 705 to align the laser output axis 706o of the OCT path 706 with a portion of the iris-corneal angle 13. For this purpose, one or more optical systems of the first optical subsystem 1001 include a window 801 connected to the cornea 3, an exit lens 710 having a surface 711 connected to the window, and a prism 752 connected to the exit lens, the exit lens and prism rotating around 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 labeled volume 720 of eye tissue is photodisrupted by the laser beam 201.

[0151]

[0188] If no additional labeled volume 720 of ocular tissue is to be treated in block 2010, the process proceeds to block 2012 and terminates. If another target volume 720 of ocular tissue needs to be imaged and treated, the process returns to block 2002, and the transmission of the OCT beam, imaging in block 2004, transmission of the laser beam in block 2006, and photodestruction in block 2008 are repeated for another portion of the iris-corneal angle along the inscribed angle of the eye containing another labeled volume of ocular tissue. For this purpose, the optics of the first optical subsystem 1001 can be rotated to align the parallel OCT optical path 707 and the angled laser optical path 706 with other portions of the iris-corneal angle 13 containing the other target volume 720 of ocular tissue.

[0152]

[0189] The method in Figure 20 discloses imaging and photodisruption in an order in which imaging precedes photodisruption, but the method is not limited to this. In some embodiments, the OCT beam 301 is transmitted to a portion of the iris-corneal angle 13, and imaging of the portion of the iris-corneal angle 13 with the OCT beam occurs before the laser beam is transmitted and the target volume of ocular tissue is photodisrupted with the laser beam 201. In other embodiments, the OCT beam 301 is transmitted to a portion of the iris-corneal angle 13, and imaging of the portion with the OCT beam is performed together with or simultaneously with the transmission of the laser beam to photodisrupt a portion of the target volume of ocular tissue and the photodisruption of the 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 carry out 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 the various aspects of this disclosure, but should be given to be the complete scope consistent with the language of the claims. All structural and functional configurations equivalent to the various components of the exemplary embodiments described throughout this disclosure, which are known to or will become known to those skilled in the art, are expressly incorporated herein by reference and are intended to be included in the claims. Furthermore, everything disclosed herein is intended to be made public, whether expressly stated in the claims or not. No element of the claims shall be construed under the provisions of 35 U.S.C. § 112, paragraph 6, unless that element is expressly described using the phrase “means” or, in the case of a method claim, using the phrase “step.”

[0154]

[0191] It should be understood that the embodiments of the present invention described herein are merely illustrative of the application of the principles of the present invention. References to the details of the embodiments illustrated herein are not intended to limit the scope of the claims, but rather the claims themselves enumerate features considered essential to the present invention.

Claims

1. A method for imaging and treating an eye that includes the optical axis, cornea, anterior chamber, and iris-corneal angle, The OCT beam of an OCT imaging device is transmitted 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, wherein the OCT output axis 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 into the portion of the iris-corneal angle at a point along the inscribed angle of the eye. The transmission of the OCT beam of the OCT imaging apparatus, The OCT beam is used to image the aforementioned portion of the iris cornea angle, The laser beam is transmitted 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 iris-corneal angle. To photodestroy at least a portion of the target volume of eye tissue with the laser beam and A method that includes this.

2. The OCT input shaft is incident on the entry surface of the first optical subsystem and transmits the OCT beam. Receiving the OCT beam along the OCT input axis, and Directing the OCT beam to the OCT output axis through the first optical subsystem. The method according to claim 1, including the method described in claim 1.

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

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

5. The method according to 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 includes a subsystem axis substantially aligned with the optical axis of the eye, an entry surface, and an entry surface spaced apart from the entry surface. The OCT beam is incident on the entry surface, and The laser beam is incident on the entry surface. The method according to claim 1.

7. The method according to claim 6, wherein the entry surface is substantially flat and the entry surface is curved in a convex shape.

8. The first optical subsystem includes a subsystem axis substantially aligned with the optical axis of the eye, and transmits the OCT beam. The method according to claim 1, comprising aligning the OCT output axis of the OCT optical path with the portion of the iris-corneal angle by rotating one or more optical systems of the first optical subsystem around the subsystem axis.

9. The one or more optical systems of the first optical subsystem include a window connected to the cornea and an exit lens having a surface connected to the window, and the one or more optical systems of the first optical subsystem are rotated about the subsystem axis. The method according to claim 8, comprising rotating the exit lens about the subsystem axis without rotating the window.

10. The method according to claim 1, wherein the first optical subsystem includes a subsystem axis substantially aligned with the optical axis of the eye, and the angled optical path and the subsystem axis are angularly offset from each other.

11. The method according to claim 1, wherein the OCT output axis and the angled optical path are angularly offset from each other.

12. The first optical subsystem includes a subsystem axis substantially aligned with the optical axis of the eye, The method according to claim 1, wherein transmitting the laser beam along the angled optical path includes 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. The method according to claim 1, wherein the transmission of an OCT beam and imaging of the portion of the iris-corneal angle with the OCT beam occur before or during photodisruption of at least a portion of the target volume of ocular tissue with the laser beam.

14. The method according to claim 1, further comprising repeatedly transmitting the OCT beam, imaging, transmitting the laser beam, and photodestructing to another portion of the iris-corneal angle along the inscribed angle of the eye.

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

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

17. The visualization observation beam of the visualization observation subsystem is transmitted along one of the OCT optical path and the angled optical path, Based on the information provided by the OCT imaging apparatus and the visual observation subsystem, the parameters of the target volume of the ocular tissue are determined. The method according to claim 1, further comprising:

18. An integrated surgical system for imaging and treating an eye having an optical axis, cornea, anterior chamber, and iris-corneal angle, A laser source configured to output a laser beam, An OCT imaging device configured to output an OCT beam, A first optical subsystem, It is connected to the aforementioned eye, The first optical subsystem is configured to receive the incidence of the OCT beam along the OCT input axis to the entry surface of the first optical subsystem and to direct the OCT beam along the OCT optical path to the OCT output axis through the first optical subsystem, wherein the OCT output axis 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 into the portion of the iris-corneal angle at a point along the inscribed angle of the eye. The first optical subsystem is configured to receive the laser beam incident on the entry surface of the first optical subsystem along the laser input axis, and to direct the laser beam through the first optical subsystem, through the cornea, and through the anterior chamber along an angled optical path into the target volume of ocular tissue in the portion of the iris-corneal angle, A second optical subsystem, The laser source, the OCT imaging apparatus, and the first optical subsystem are optically connected. The laser beam is transmitted 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 connected to the laser source, the OCT imaging apparatus, and the second optical subsystem, The OCT imaging apparatus is controlled to output the OCT beam to the second optical subsystem and to image the portion of the iris corneal angle with the OCT beam. A control system configured to output the laser beam to the second optical subsystem and control the laser source to photodestroy at least a portion of the target volume of eye tissue, and An integrated surgical system, including...

19. The first optical subsystem includes an entry surface, and the first optical subsystem is It is arranged to receive the incidence of the OCT beam onto the entry surface along the OCT input axis, and The OCT beam is configured to be directed toward the OCT output axis. The integrated surgical system according to claim 18.

20. The integrated surgical system according to 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. The integrated surgical system according to claim 19, wherein the first optical subsystem includes at least one reflective surface and is configured to reflect the OCT beam toward the OCT output axis with respect to the at least one reflective surface.

22. The integrated surgical system according to claim 18, wherein the first optical subsystem includes a subsystem axis, and when connected 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 surface, and an entry surface spaced apart from the entry surface. The incident OCT beam onto the aforementioned entry surface is received, The integrated surgical system according to claim 18, which is configured to receive the incidence of the laser beam onto the entry surface.

24. The integrated surgical system according to claim 23, wherein the entry surface is substantially flat and the entry surface is curved in a convex shape.

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

27. The integrated surgical system according to claim 18, wherein the first optical subsystem includes a subsystem axis, and the angled optical path and the subsystem axis are angularly offset from each other.

28. The integrated surgical system according to claim 18, wherein the OCT output axis and the angled optical path are angularly offset from each other.

29. The first optical subsystem includes a subsystem axis and an entry surface, and the first optical subsystem, The incident laser beam onto the entry surface along the laser input axis is received, The subsystem is positioned so as to be angularly offset from the subsystem axis, The integrated surgical system according to claim 18.

30. The system further includes a visualization observation subsystem configured to output an illumination beam and receive a visual observation beam, The integrated surgical system according to claim 18, wherein the first optical subsystem is arranged and configured to direct the illumination beam and the visual observation beam, respectively, along either the OCT optical path or the angled optical path.

31. A focusing objective lens head for connecting to a patient interface having a window configured to connect to the cornea of ​​an eye having an optical axis, anterior chamber, and iris-corneal angle, The exit lens is configured to be optically connected to the window of the patient interface so as to align the axis of the exit lens with the optical axis of the eye, and A prism mechanically and optically connected to the aforementioned exit lens. Includes, The prism and the exit lens form an optical assembly, and the optical assembly is The prism receives the incidence of an OCT beam along the OCT input axis onto the entry surface of the prism, and directs the OCT beam so that 1) it is substantially parallel to the axis of the exit lens, 2) it is radially offset from the axis of the exit lens, and 3) it extends through the exit lens into the portion of the cornea and the iris-corneal angle. Directional setting for the OCT output axis, A focusing objective lens head configured to receive a laser beam incident on the entry surface of the exit lens along the laser input axis, and to direct the laser beam through the exit lens, through the cornea, and through the anterior chamber along an angled optical path into a target volume of ocular tissue located at the iris-corneal angle.

32. The focusing objective lens head according to claim 31, further comprising a housing, wherein the optical assembly is fixed to the housing.

33. The focusing objective lens head according to claim 32, wherein the housing is configured to be directly connected to the patient interface.

34. The focusing objective head according to claim 32, wherein the housing is configured to be indirectly connected to the patient interface via an interface structure configured to mechanically connect the housing and the patient interface.

35. The focusing objective lens head according to 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. The focusing objective head according to claim 32, further comprising an OCT mirror fixed to the housing, which receives the OCT beam and is positioned to direct the incidence of the OCT beam along the OCT input axis to the entry surface of the prism.

37. The focusing objective head according to claim 36, further comprising an OCT focusing lens fixed to the housing, which is arranged to receive the OCT beam and to direct the OCT beam to the OCT mirror.

38. The focusing objective head according to claim 32, further comprising a laser focusing lens fixed to the housing, which receives the laser beam and is arranged to direct the incidence of the laser beam along the laser input axis to the entry surface of the exit lens.

39. The focusing objective lens head according to claim 38, further comprising a laser scanner fixed to the housing and arranged to receive the laser beam and direct the laser beam toward the laser focusing lens.

Images