Docking station for use in ophthalmic procedures

Abstract

A docking device for intraocular surgery includes an upper rim having a second diameter, a lower rim having a first diameter and a bottom surface with at least one opening, and a sidewall extending between the upper and lower rims. There is also an arm having a first portion coupled to a central portion of the upper and lower rims and a second portion configured for connection to a positioning arm. The lower rim also has a lower surface with an adapted contour configured to be secured to the sclera and / or conjunctiva of a subject's eye. Optionally, the lower surface of the upper rim is adapted and configured for releasable engagement with the upper surface of the lower rim. Other variations include a detachable coupler that allows the suction surface to remain coupled to the subject's eye while other portions of the docking device are released.

Description

[Technical Field]

[0001] Priority claims

[0001] This application claims priority to U.S. Provisional Application No. 63 / 478,851, entitled "DOCKING STATION FOR USE IN OPHTHALMIC PROCEDURES," filed January 6, 2023, the contents of which are incorporated herein by reference in their entirety.

[0002] Incorporation by Reference

[0002] All publications and patent applications mentioned in this specification are incorporated by reference in their entirety into this specification to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. Field

[0003]

[0003] This application relates to systems and tools for use as an interface during ophthalmic procedures. [Background technology]

[0004] Intraocular conditions are treated through delicate microsurgical procedures that rely on visualizing delicate tissues within the small, confined spaces of the eye. Optical coherence tomography (OCT) can be used to improve intraocular visualization by imaging small membranes and anatomical features, revealing features that would otherwise remain invisible or difficult to perceive to the surgeon, thereby improving surgical outcomes. Additionally, OCT can provide fast, small-scale, and accurate measurements, enabling the possibility of real-time guidance for surgeons and autonomous robotic surgical systems. In addition to OCT, surgical microscopes can be used to visualize features inside the eye. In addition to imaging devices, laser-based manipulation devices, such as femtosecond laser systems, can be used to cut, slice, or physically alter the eye.

[0005] Despite the advantages of OCT systems, surgical microscopes, and laser-based surgical devices, the quality of both imaging and optical manipulation systems can be affected by the nature of the surgical environment. First, patient movement and the constant movement of surgical tools within the eye can result in high levels of noise, data distortion, and physical inaccuracies within the visualized area. Second, the quality of OCT scans can depend on the presence of a fluid medium, particularly between the imaging probe and the anatomical structure being scanned. Therefore, the presence of a fluid medium not only improves visualization quality but also maintains hydration of the eye. Furthermore, imaging systems are placed in the sterile field of the patient, but cannot be properly sterilized themselves, limiting their use and integration with other systems, such as robotic surgical systems. Furthermore, while docking systems may exist, none allow surgical instruments to manipulate the eye simultaneously while the docking is activated. Enabling simultaneous docking and instrument manipulation would provide some or all of the above benefits without the need for surgical manipulation.

[0006]

[0006] Additional challenges are presented with regard to ocular stabilization. First, there is little constraint on the movement of the patient's eye during intraocular procedures. Second, the eye is subject to movement and displacement due to the forces and torques of surgical tools during surgical procedures. Third, unconstrained movement hinders successful implementation of robot-assisted or fully robotic applications and can reduce the quality of visualization of the intraocular workspace. Eye movement while surgical instruments are inside the eye can cause severe and / or irreversible damage to the ocular anatomical structures. These factors highlight additional unmet requirements for eye stability in docking systems. Summary of the Invention

[0007]

[0007] Against this background, there is a need for continued improvements in the area of ​​eye stabilization in systems suited to advanced and emerging intraocular surgical systems and techniques.

[0008] In various embodiments, a docking device for intraocular surgery is described. The device includes an upper rim having a second diameter; a lower rim having a first diameter and a bottom surface with at least one opening; an arm having a first portion connecting with a central portion of the upper and lower rims and a second portion configured for connection to a positioning arm; and a lumen in or along the arm that communicates with the at least one opening. In additional aspects, the first end of the upper rim and the second end of the upper rim define an opening of between 30 degrees and 180 degrees. In additional embodiments, the first diameter is the same as the second diameter. Additionally or optionally, the first diameter is larger than the diameter of the limbus of the subject eye. In other embodiments, the first diameter is smaller than the second diameter. In one aspect, the lower rim further includes a bottom surface having a curvature, profile, or durometer adapted and configured to be secured to the sclera and / or conjunctiva of the subject eye. In another embodiment, the lower surface of the upper rim is adapted and configured for releasable engagement with the upper surface of the lower rim. In yet an additional aspect, there is an opening between the central portion and the first end of the upper rim or between the central portion and the second end of the upper rim.

[0009] Various alternative embodiments also provide one or more methods for stabilizing an eye during an ophthalmic procedure. In one embodiment, there is a step of positioning a lower surface of a suction ring on the eye such that a central portion of the suction ring is at, above, or adjacent to the meniscus and caruncle, and an opening portion of the suction ring is opposite the central portion, the opening being in the range of 30 degrees to 180 degrees. There is then a step of applying a vacuum to the suction ring to secure the lower surface of the suction ring to the surface of the sclera and / or conjunctiva, the suction ring at least partially surrounding the cornea of ​​the eye. There is also a step of performing an ophthalmic procedure on the eye using an instrument passed through the opening in the suction ring. In additional embodiments, there is also a step of manipulating a positioning arm of an ophthalmic imaging and illumination system prior to the positioning and applying vacuum steps so that the suction ring is aligned for use with the ophthalmic imaging and illumination system and for providing access to the eye using the opening in the suction ring. In yet another embodiment, there is a step of releasably coupling the suction ring to the positioning arm prior to the manipulating the positioning arm. Additionally, the above method can be modified so that the suction ring is decoupled from the positioning arm by moving the patient's head during the ophthalmic procedure.

[0010] In yet another alternative embodiment, a docking device for intraocular surgery is provided. The device has an upper rim having a second diameter, a lower rim having a first diameter and a bottom surface with at least one opening, and a sidewall extending between the upper and lower rims. There is also an arm having a first portion connecting with a central portion of the upper and lower rims and a second portion configured to connect to a positioning arm. There is also a lumen in or along the arm that communicates with the at least one opening, and the first end of the upper rim and the second end of the upper rim define an opening between 30 degrees and 180 degrees. In one aspect, the first diameter is the same as the second diameter. In another aspect, the first diameter is larger than the diameter of the limbus of the subject eye. In yet another aspect, the first diameter is smaller than the second diameter. In another alternative, the lower rim also has a bottom surface with a curvature, profile, or durometer adapted and configured to be secured to the sclera and / or conjunctiva of the subject eye.

[0011] Additionally or optionally, the lower surface of the upper rim is adapted and configured for releasable engagement with the upper surface of the lower rim. In some variations, there is an opening between the central portion and the first end of the upper rim, or between the central portion and the second end of the upper rim. Furthermore, a detachable coupling can also be provided that allows other portions and systems of the docking device to be detached while the suction surface remains coupled to the treated eye. In one embodiment, there is a detachable coupling disposed between the location arm and the upper rim of the docking device, between the upper rim of the docking device and the upper portion of the sidewall of the docking device, or between the lower rim of the docking device and the lower portion of the sidewall of the docking device.

[0012] Various embodiments of the docking device and system can also be used to provide a set of advantageous methods for stabilizing and hydrating a subject's eye. In one aspect, there is a method for stabilizing a subject's eye during an ophthalmic surgical procedure. The subject's eye is stabilized by positioning a docking device having a lower surface with an adsorption ring over the subject's eye so that a central portion of the adsorption ring is at, above, or adjacent to the meniscus and caruncle of the subject's eye, and an opening portion of the adsorption ring is opposite the central portion. The opening is between 30 degrees and 180 degrees. A vacuum is then applied to the adsorption ring to secure the lower surface of the adsorption ring to the sclera and / or conjunctiva. The adsorption ring at least partially surrounds the cornea of ​​the eye. Thereafter, the ophthalmic surgical procedure is performed on the subject's eye using a surgical instrument passed through the opening in the adsorption ring. In one variation, there is also a step of hydrating the eye while the docking device is attached to the subject's eye. In another variation, there may be a step of manipulating the positioning arm of the ophthalmic imaging and illumination system prior to the positioning step and the applying vacuum step so that the suction ring is aligned for use with the ophthalmic imaging and illumination system and for providing access to the eye to be treated using the opening in the suction ring.

[0013] Additionally or optionally, prior to the step of manipulating the positioning arm, there is a step of releasably coupling the docking device to the positioning arm. In another variation, a detachable coupler and other features of the docking device can be implemented so that if the patient's head moves during the ophthalmic surgical procedure, that movement can be converted into a decoupling action to disengage the suction ring from the positioning arm. In various embodiments, this disengagement is achieved using a detachable coupler integrated into the docking device or system. In some embodiments, the suction ring remains coupled to the treated eye after activation of the detachable coupler. Further variations are contemplated in which the detachable coupler is positioned between the positioning arm and the upper rim of the docking device, between the upper rim of the docking device and the upper part of the sidewall of the docking device, or between the lower rim of the docking device and the lower part of the sidewall of the docking device. Optionally, a step of hydrating the treated eye using an eyewash system coupled to the positioning arm may also be provided.

[0014]

[0014] The various features of the non-limiting embodiments disclosed and described herein will be better understood with reference to the accompanying drawings, in which: [Brief explanation of the drawings]

[0015] [Figure 1]

[0015] Figure 1 is a perspective view of a docking device having a suction ring and a support ring. There is also a hydration nozzle adjacent to the support ring. Also shown is a suction port in communication with the suction ring. [Figure 2]

[0016]

[0023] Figure 2 is a perspective view of a docking device having an adsorption ring and support ring similar to that of Figure 1. In contrast to Figure 1, Figure 2 shows the support arm and hydration nozzle outlet integral with the support arm assembly. The absorption port is attached to the absorption tube and is not visible in this view. [Figure 3A]

[0017] Figure 3A is a top perspective view of the prototype docking device in place on a cadaver eye. The diameter of the lower rim adjacent to the higher rim is smaller than the upper rim. Additionally, two openings in the rim sidewall adjacent to the central portion are visible in this view. The angle of the openings between the first and second ends of the rim is visible in this view. [Figure 3B]

[0018] Figure 3B is a right front view of the prototype docking device in place on the cadaver eye of Figure 3 A. This view provides additional perspective on the relative position of the central portion to the edge of the rim to define an opening for surgical access to the eye stabilized by the suction ring. [Figure 3C]

[0019] Figure 3C is a top view of the opening between the first and second ends of the rim of the prototype docking device in place on the cadaver eye of Figure 3A. The angle of the opening provided for surgical access is clearly shown in this view. Additionally, this view also shows additional access points possible through openings in the first and second rim sidewalls. [Figure 4]

[0020] 3A-3C are top views of the prototype in place on the cadaver eye, shown in phantom, with the remaining surrounding ocular anatomy added around the cadaver eye. This view also shows the relationship of the central portion to the corners of the eye, and the relationship of the first and second edges to the angle of the opening. [Figure 5A]

[0021] FIG. 5A is a side view of a modified embodiment of the docking device of FIGS. 3A to 3C. [Figure 5B]

[0022] 5B is a perspective view of the support ring over the top surface of the upper rim of the docking device prior to engagement, in which the location and alignment of the detent features on the top surface of the upper rim are visible. [Figure 5C]

[0023] FIG. 5C is a bottom view of the view of FIG. 5B showing details of the mating features on the bottom surface of the support ring. [Figure 6]

[0024] 1 is a perspective view of an embodiment of a docking device in place on the eye and coupled with a positioning arm below the location of representative imaging and illumination components, with the area of ​​surgical access provided by the opening in the docking device indicated and visible. [Figure 7]

[0025] Figure 7A is a top view of a patient's head prepared for a surgical procedure using the docking device shown in Figure 6. This view shows the relationship of the forehead-mounted push rod in contact with a portion of the positioning arm.

[0026] FIG. 7B is a view of the top of the patient's head of FIG. 7A showing the result of uncoupling the docking device when movement of the patient's head moves the positioning arm out of the docking position and disengages the docking device. [Figure 8]

[0027] FIG. 8A is a side view of the suction ring attached to the subject's eye, with the rim and support ring adjacent and in close proximity to the top surface of the support ring.

[0028] FIG. 8B is a side view of the suction ring attached to the eye of a patient, similar to FIG. 8A, with the rim and support ring in contact with the top surface of the support ring but misaligned.

[0029] FIG. 8C is a side view of the suction ring, similar to FIG. 8A, attached to the subject's eye, with the rim and support ring contacting, engaging, and aligning with the upper surface of the support ring. [Figure 9]

[0030] FIG. 1 is a flow diagram illustrating a method for stabilizing an eye during an ophthalmic procedure. [Figure 10]

[0031] FIG. 1 is a flow diagram illustrating a method for the ophthalmic docking system to respond to a sudden event. DETAILED DESCRIPTION OF THE INVENTION

[0016]

[0032] The various alternative embodiments described herein provide examples of intraocular docking devices that simultaneously provide: (1) visualization, (2) eye stabilization, and (3) surgical tool access. Additionally, each embodiment provides a clear line of sight to the imaging and illumination systems. Stabilization systems are also described that provide appropriate structural engagement for efficient placement of the docking structure while stabilizing the eye, taking into account the operational envelope, including surgical tool workflow, tool positioning trajectories, and the movement of each tool used during the surgical procedure. Furthermore, various docking device embodiments enable eye hydration to maintain moisture on the eye surface, as well as a fluid barrier to help maintain vision. Hydration can be provided manually or as part of an on-board hydration device, as described in further detail below.

[0017]

[0033] For example, there is a docking device for intraocular surgery that includes an upper rim having a second diameter, a lower rim having a first diameter and a bottom surface with at least one opening, an arm having a first portion connecting with a central portion of the upper and lower rims and a second portion configured to connect to the positioning arm, and a lumen in or along the arm that communicates with the at least one opening, wherein the first end of the upper rim and the second end of the upper rim define an opening of 30 to 180 degrees.

[0018]

[0034] According to one example of the docking device, the first diameter is the same as the second diameter.

[0019]

[0035] In one example of the docking device, the first diameter is greater than the diameter of the limbus of the treated eye.

[0020]

[0036] In one example of the docking device, the first diameter is smaller than the second diameter.

[0021]

[0037] According to one example of the docking device, the lower rim further includes a lower surface having a curvature, profile, or durometer adapted and configured to be secured to the sclera and / or conjunctiva of the treated eye.

[0022]

[0038] According to one example of a docking device, the lower surface of the upper rim is adapted and configured for releasable engagement with the upper surface of the lower rim.

[0023]

[0039] According to one example of the docking device, there is an opening between the central portion and the first end of the upper rim or between the central portion and the second end of the upper rim.

[0024]

[0040] FIG. 1 is a perspective view 100 of a docking device having a suction ring and a support ring. Also shown is a hydration nozzle 102 with a nozzle outlet 104 adjacent to the support ring 106. Also shown is a suction port 108 that communicates with a suction ring 110. FIG. 1 illustrates the main features of the docking device 100. The suction ring 110 connects to the eye and secures the eye to the suction ring 100 through suction, thereby securing the eye to the docking device 100 itself and holding the eye in place. To support the suction ring 110, the support ring 106 adds structural stability to the suction ring and connects to a support arm 112. The support arm 112 then interfaces with an external positioning device to assist in positioning the entire docking device on the patient's eye. The suction ring 110 receives suction force through the suction port 108. Also shown is a connection 112A between the support arm 112 and the support ring 106.

[0025]

[0041] In one aspect, an embodiment of the present invention is provided that allows for the simultaneous use of the docking device 100 with surgical instruments operating inside the eye. Many conventional designs prevent the use of this combination due to either or both of a rigid rim and a fully encircling docking design. In contrast, embodiments of the docking device 100 according to the present invention can have a partially encircling design, a selectively encircling design, and an open rim sidewall design that allows access for additional surgical tools or accessories, as described herein. Furthermore, embodiments of the docking device advantageously incorporate a partial "ring" design that secures the eye nasally while leaving the temporal side of the eye open for tool access. (See FIG. 4 ). The docking device, in various embodiments, includes an upper rim for coupling with a support arm and various accessories (see FIGS. 1, 2, 3A-3C, 6, 7A, and 7B) and a lower rim adapted and configured for coupling with a treatment eye in a variety of different configurations (see FIGS. 1, 2, 3A-3C, and 5A-5C). Various shapes and orientations of the lower and upper rims are also understood with respect to the various configurations described with respect to FIG. 4. Additionally, or optionally, the sidewall extending between and joining the upper and lower rims may be a continuous sidewall, as best seen in FIGS. 1 and 2, or may have a discontinuous or open sidewall configuration as shown in FIGS. 3A-3C and 5A-5C.

[0026]

[0042] FIG. 1 shows an exemplary partial suction ring 110 / support ring 106 having a first end 110A, a second end 110B, a rim wall 110C, a central portion 110D, an opening 110E, and an opening angle 110F.

[0027]

[0043] In another embodiment, the docking device can incorporate an active hydration system to maintain a fluid layer and ensure adequate hydration during the surgical procedure. As shown in Figure 1, there may be a hydration port 114 connected to an external nozzle (not shown).

[0028]

[0044] Optionally, the hydration outlet may be integral with the support ring or other structure and connected to appropriate tubing as in Figure 2. Figure 2 is a perspective view 200 of a docking device having a suction ring and support ring similar to that of Figure 1. In contrast to Figure 1, Figure 2 shows the support arm 212 and hydration nozzle outlet 204 integral with the support arm assembly. The suction port is attached to suction tube 208A and is not visible in this view.

[0029]

[0045] The hydration function of the docking device is similar to that of an assistant surgeon or nurse during a traditional surgical procedure, who maintains corneal hydration using a hydration syringe and cannula. The fluid can be balanced salt solution (BSS), medication, or other hydration fluid.

[0030]

[0046] One variation is an integrated hydration nozzle / hydration tube 202, as shown in FIG. 2. Another variation is to secure commercially available cannulas and / or nozzles to the docking system. Another variation is to integrate dedicated hydration ports into the structural docking ring and / or suction ring, either from one side, all sides, or some combination of the two. Also shown is a coupling device on the support ring 206, such as a magnet 202M. Also shown are first end 210A, second end 210B, rim wall 210C, central portion 210D, opening 210E, and opening angle 210F.

[0031]

[0047] 3A is a generally top perspective view of the prototype docking device in place on a cadaver eye. The lower rim 310CB adjacent the eye is smaller in diameter than the upper rim 310CA. Additionally, two openings in the rim sidewall 310R adjacent the central portion 310D are visible in this view. The opening angle 310F between the first end 310A and the second end 310B of the rim 310C is visible in this view. Pins or other fixation devices 310P may serve to secure or stabilize the cadaver eye to the base floor 310BF or other surface, or to attach a cover onto which the cadaver eye rests.

[0032]

[0048] Figure 3B is a right front view of the prototype docking device in place on the cadaver eye of Figure 3 A. This view provides additional perspective on the relative position of central portion 310D to the edge of rim 310C to define opening 310E for surgical access to the eye stabilized by suction ring 110 (from Figure 1).

[0033]

[0049] Figure 3C is a top view of the opening between the first end 310A and the second end 310B of the rim 310C of the prototype docking device in place on the cadaver eye of Figure 3A. The angle 310F of the opening provided for surgical access is clearly shown in this view. Additionally, this view also shows additional access points possible via openings 319R in the first and second rim sidewalls.

[0034]

[0050] According to a particular example, the diameter of the lower portion 310CB of the rim is adapted and sized to be wider than the cornea 302 in use. In this view of the cadaver eye, the entire cornea 302 and a portion of the sclera 305 around the cornea 302 are visible. The opening angle 310F between the first end 310A and the second end 310B of the rim 310C is also shown. In additional embodiments, the opening 310E is selected to provide a variety of different approach angles to the limbus 302.

[0035]

[0051] FIG. 4 shows a top view 400 of the prototype in place on the donor eye of FIGS. 3A-3C in phantom (dotted) lines, with the remaining surrounding ocular anatomy added around the donor eye. This view also shows the relationship of the central portion 410D to the corners of the eye, as well as the relationship of the first and second edges 410A and 410B to the opening angle 410F. Also shown is the relationship of the lower rim diameter d1 (from FIG. 3C), which extends along a straight line, e.g., a line between 3:00 and 9:00, when the suction ring 110 (from FIG. 1) interfaces with the surface of the sclera 405, to the overall visibility of at least the entire iris and / or cornea 402. It is understood, therefore, that variations of the present invention may touch all, part, or none of the cornea, or all, part, or none of the sclera 405 / conjunctiva. Also shown are the boundary between the sclera / conjunctiva and the eyelid 401, and the pupil 404.

[0036]

[0052] In use, the central portion 410D of the docking device at least partially covers the semilunar fold 406 and caruncle 407 (i.e., the corner of the eye) or a portion of the sclera 405 or conjunctiva. When the bottom surface of the suction ring 110 (from FIG. 1) engages the sclera 405 / conjunctiva, substantially all of the cornea 402 is visible, or all of the cornea 402 and a ring of sclera 405 between the cornea 402 and the inner edge of the suction ring 110 (from FIG. 1) is visible. The limbus can be accessed through the opening.

[0037]

[0053] The opening allowing access for the procedure is defined as the area between the first end 410A and the second end 410B of the suction ring 110 (from FIG. 1). Using a clock face with 12:00 (12 o'clock) at the center portion 410D near the corner 407 of the subject's eye, 6:00 (6 o'clock) is at the opposite corner of the subject's eye. In an embodiment where the first end is at 9:00 (9 o'clock) and the second end is at 3:00 (3 o'clock), the opening angle 410F is 180 degrees. If the ends are at 4 and 8, the opening extends from 4-5-6-7-8. Similarly, if the ends are at 5 and 7, the opening extends from 5-6-7. The ends do not need to be symmetrically spaced so that the openings are evenly spaced around the 6:00 (6 o'clock) position. Depending on the location and approach angle for the intraocular procedure, the openings and engagement surfaces can be adjusted to provide an opening at the optimal approach angle.

[0038]

[0054] Alternatively, in some embodiments, the central portion 410D remains positioned over the corner of the eye closest to the nose 408, but the opening defined by the positioning of the first end 410A and second end 410B of the suction rim wall 110C (from FIG. 1) can be positioned in other locations that are not symmetrical about the 6:00 (six o'clock) position as shown. Other docking devices may have openings positioned to support different desired surgical approach vectors to the eye stabilized by the suction ring 110 (from FIG. 1).

[0039]

[0055] Figure 5A is a side view of a variation of the docking device of Figures 3A-3C. As shown therein is a kinematic ball coupler 502K, which, according to a particular embodiment, may be located on the system arm 112 (from Figure 1). The suction ring 510 also has an opening 510O for vacuum attachment to the surface of the eye. Also shown are the intake tube 508, a side wall 510C, an upper portion of the side wall 510D, and a side wall opening 510R.

[0040]

[0056] Figure 5B is a perspective view of the support ring 506 above the top surface of the upper rim (310CA) (from Figure 3A) of the docking device prior to engagement. In this view, the location and alignment of the detent features on the upper surface 510CAB of the upper rim are visible. Also shown are the first end 510A, the second end 510B, the sidewall 510C, the opening 510E, and the opening angle 510F.

[0041]

[0057] FIG. 5C is a bottom view of the view of FIG. 5B showing details of mating features on the bottom surface of the support ring, such as magnetic coupling 502M.

[0042]

[0058] 6 is a perspective view of an embodiment of a docking device 610 in place on the eye and coupled with a positioning arm 612 below the location of a representative imaging and illumination component 602. The area of ​​surgical access 614 provided by an opening in the docking device 610 is shown and visible in this view. Also shown is an exemplary connector 606 between the docking device 610 and the positioning arm 612, as well as a rim opening access 608. An upper arm or positioning arm 612U is also shown.

[0043]

[0059] Advantageously, embodiments of the present invention are specifically designed to enhance visualization of the eye from a wide range of viewing angles while also facilitating illumination of the eye. In some embodiments, the docking device is adapted and configured to optimize visualization of the interior of the eye while not obstructing or interfering with the microscope or OCT field of view. (See diagrams in FIGS. 3A-3C and 6.) Similarly, the docking device is specifically designed to optimize external illumination through its "open" design, as shown in FIG. 6 in the context of an exemplary illumination and imaging system. The opening in the sidewall between the upper and lower rims is useful in this regard. In additional alternative embodiments, any of a variety of illumination sources can be integrated into or attached to portions of the docking device in any location suitable for that purpose.

[0044]

[0060] In some embodiments of the present invention, passive methods can be incorporated into the overall procedure for using the docking device to account for patient head and / or eye movement. In some aspects, the docking device is fixed to the visualization system but is designed to allow and / or facilitate disengagement / movement of itself in the event of patient movement. This may be done for safety or improved visualization of the intraocular workspace, among other reasons.

[0045]

[0061] One variation of a passive actuation / response that does not require active sensing or motor input to function is the push bar shown in Figures 7A and 7B.

[0046]

[0062] FIG. 7A is a top view of a patient's head prepared for a surgical procedure using the docking device shown in FIG. 6. This view illustrates the relationship of a forehead-mounted push rod 702 in contact with a portion of a positioning arm 712. As shown, there is a target eye (on the patient's head 760) to which a docking device 750 is attached. In one embodiment, the forehead pad 704 with the push rod may not be coupled to the system arm 712. In other embodiments, the forehead pad 704 with the push rod couples with the system arm 712 or with the support arm 112 (from FIG. 1). The support arm 112 may then couple with the system arm 712. According to certain embodiments, the docking device couples with an exemplary positioning system arm 712, and moving (712A) a docking device 752A attached to the target eye can move (753) the positioning system arm 712. Also shown are the support ring 706, the suction ring 710, and the rim wall 710C. The system arm 712 may couple to a positioning arm 712U, which may couple to other components 702, which may be other connections, imaging systems, consoles, robotic systems, and the like.

[0047]

[0063] 7B is a view of the top of the patient's head of FIG. 7A illustrating the result of decoupling 752 the docking device when movement of the patient's head disengages 752 the positioning arm from the docking position and disengages 752 the docking device. According to certain embodiments, disengaging 752 or moving 752A the docking device allows movement 753 of the system arm.

[0048]

[0064] 7A and 7B, an external "push rod" is mounted to the patient's head (e.g., via a forehead pad) 704 and contacts the docking arm 712. When the patient's head moves forward (749), the push rod 704 pushes the docking arm 712 out of the way, automatically decoupling the docking device from the patient's eye (e.g., decoupling from the suction ring 752).

[0049]

[0065] As a key component of the ability to quickly connect / disconnect the docking device from its structural support elements, alternative embodiments incorporate various means for achieving the above requirements. This reproducible process and capability can be thought of as a three-step process: approach, contact, and coupling, as detailed below. After coupling for use in a surgical procedure, uncoupling may occur through an automated process, a manual process, or a decoupling process, as shown in Figures 7A and 7B. It is understood that the coupling forces used between various components of the docking device and the associated portions of the positioning arm can be mechanical, magnetic, pneumatic, vacuum-based, etc. For illustrative purposes, Figures 8A, 8B, and 8C depict a schematic version provided to illustrate a vacuum-based design variation.

[0050]

[0066] 8A shows a side view of a suction ring attached to a subject's eye, with the rim and support ring adjacent and approaching the upper surface of the support ring (800). As shown, there is an approaching phase 800 in which the rim and support ring pass over / approach the upper surface of the suction ring 810 (801). Here, the subject's eye 802 with the suction ring 810 can be secured together via docking suction 812A (812). Also shown is a cup 811 with a controllable vacuum 820 applied, causing the rim wall 110C (from FIG. 1) and support ring 106 (from FIG. 1) to move over or approach the upper surface of the suction ring 810.

[0051]

[0067] 8B is a side view of the suction ring attached to a treatment eye, similar to FIG. 8A, with the rim and support ring in contact with the upper surface of the support ring but misaligned (825). As shown, there is a contact phase 825 where the rim wall 110C (from FIG. 1) and the support ring 106 (from FIG. 1) are in contact with the upper surface of the support ring but slightly misaligned (826). According to certain embodiments, such misalignment is acceptable.

[0052]

[0068] FIG. 8C is a side view of the suction ring attached to a subject's eye, similar to FIG. 8A, with the rim wall 110C (from FIG. 1) and support ring 106 (from FIG. 1) contacting, engaging, and aligning with the top surface of the support ring (850). As shown, there is a coupling phase 850 in which the rim wall 110C (from FIG. 1) and support structure 106 (from FIG. 1) engage with the top surface of the suction ring 810 in the proper alignment (851) for the surgical procedure to begin. The coupling process or mating coupling (850) ensures proper alignment 851 between the bottom surface of the rim wall 110C and the top surface of the suction ring 810. Different levels of coupling force are possible depending on the particular embodiment.

[0053]

[0069] In addition to the coupling force, the docking device may incorporate kinematic coupling elements that ensure the docking attaches in the same place upon attachment. These couplers can be either precision "kinematic couplers" or some other physical, active, or passive means. Their incorporation into the docking device ensures that the coupling is highly accurate, i.e., it couples in nearly the same position every time. Figures 5A, 5B, and 5C show one type and arrangement of coupling approaches.

[0054]

[0070] FIG. 5A is a side view of a variation of the docking device of FIGS. 3A-3C. The engagement of kinematic ball coupler 502K between the bottom surface of support ring 506 and the upper rim (FIGS. 3A-310CA) is shown in this view. FIG. 5B is a perspective view of support ring 506 above the upper surface of the top of docking device rim 510C prior to engagement. The location and alignment of detent features on the upper rim's upper surface 510CAB are visible in this view. FIG. 5C is a bottom view of the view of FIG. 5B showing details of mating features on the bottom surface of the support ring, such as magnetic coupler 502M. Taken together, it will be appreciated that a variety of different release coupler configurations may exist in various alternative docking device embodiments. In one embodiment, the release coupler is between the upper rim and the top of the sidewall, as shown in FIGS. 5A and 5B. In yet another configuration, the release coupler may be between the bottom of the sidewall and the lower rim, as shown in FIG. 5C. In one embodiment, the release coupler is positioned so that the portion of the docking device that is coupled to the eye upon activation remains coupled to the eye, and the docking device is released by the action of the release coupler at another location. Thus, there may be additional release coupler variations at the connection point between the support arm and the upper rim. See, for example, FIG. 3B, 310D, where such a release coupler may be positioned at the junction adjacent the upper rim.

[0055]

[0071] FIG. 9 is a flow diagram illustrating a method 900 for stabilizing an eye during an ophthalmic procedure.

[0056]

[0072] Method 900 begins at block 905 by positioning the lower surface of a suction ring on the eye such that the central portion of the suction ring is at, above, or adjacent to the meniscus and caruncle, and the opening portion of the suction ring is opposite the central portion, the opening being in the range of 30 degrees to 180 degrees.

[0057]

[0073] The method 900 continues at block 910 by applying a vacuum to the suction ring to secure the lower surface of the suction ring to the surface of the sclera and / or conjunctiva, the suction ring at least partially surrounding the cornea of ​​the eye.

[0058]

[0074] Next, at block 915, the method 900 continues with the ophthalmic treatment of the eye using the instrument that passed through the opening in the suction ring.

[0059]

[0075] According to an embodiment of method 900, method 900 further includes manipulating a positioning arm of the ophthalmic imaging and illumination system prior to the positioning and applying vacuum steps so that the suction ring is aligned for use with the ophthalmic imaging and illumination system and for providing access to the eye using an opening in the suction ring.

[0060]

[0076] According to an embodiment of method 900, method 900 further includes releasably coupling a suction ring to the positioning arm prior to manipulating the positioning arm.

[0061]

[0077] According to an embodiment of the method 900, the method 900 further includes moving the patient's head during the ophthalmic procedure to decouple the suction ring from the positioning arm.

[0062]

[0078] FIG. 10 is a flow diagram illustrating a method 1000 for a docking system to respond to a sudden event during an ophthalmic procedure (eg, during eye surgery).

[0063]

[0079] At block 1005, the method begins by positioning an ophthalmic docking system having a proximal suction ring over the patient's eye, the suction ring being attached to the rim, support ring, lower arm, and upper arm of the ophthalmic docking system.

[0064]

[0080] Method 1000 continues at block 1010 by receiving a sudden trigger event including one or more of: (i) a patient's head or body movement, (ii) a malfunction of the ophthalmic docking system, and (iii) an interference with the ophthalmic docking system.

[0065]

[0081] Method 1000 ends at block 1015 with decoupling the ophthalmic docking system from the eye at one or more release points of the ophthalmic docking system distal to the suction ring, including (i) an interface between the rim and the suction ring, (ii) an interface between the support ring and the rim, and (iii) an interface between the lower arm and the support ring.

[0066]

[0082] In still other embodiments, the docking devices described herein may be adapted and configured for integration or interchangeable coupling with various sensors to detect, measure, or sense various measurable parameters related to the function or performance of a surgical tool component or assembly, or additionally or optionally, to force, pressure, torque, humidity, stress, temperature, etc. in the surgical field. In various alternative configurations, the sensors can either be embedded in the docking system / structure itself or incorporated into an external surface for ease of access or to facilitate detection capabilities.

[0067]

[0083] As used herein, when a feature or element is referred to as being "on" another feature or element, it can be directly on the other feature or element, or there may be intervening features and / or elements present. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements present. Also, when a feature or element is referred to as "connected," "attached," or "coupled" to another feature or element, it will be understood that it can be directly connected, attached, or coupled to the other feature or element, or there may be intervening features and / or elements present. In contrast, when a feature or element is referred to as "directly connected," "directly attached," or "directly coupled" to another feature or element, there are no intervening features or elements present. Although described or illustrated with respect to one embodiment, features and elements so described or illustrated may be applicable to other embodiments. Additionally, references to a structure or feature being disposed "adjacent" another feature will be understood by those skilled in the art to mean that there may be portions that overlap or underlie the adjacent feature.

[0068]

[0084] The terms used herein are for the purpose of describing particular embodiments only and are not intended to be limiting of the invention. For example, as used herein, the singular forms "a," "an," and "the" are intended to include the plural forms unless the context clearly dictates otherwise. Furthermore, it will be understood that the terms "comprise" and / or "comprising," as used herein, specify the presence of stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ."

[0069]

[0085] To describe the relationship of one element or feature to another element or feature shown in the figures, spatially relative terms such as "below," "below," "below," "above," "above," etc. may be used herein for ease of description. It will be understood that spatially relative terms are intended to encompass different orientations of the device during use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures were inverted, an element described as "below" or "below" another element or feature would be oriented "above" the other element or feature. Thus, the exemplary term "below" can encompass both an orientation of above and below. A device may be oriented in other ways (rotated 90 degrees or to other orientations), and the spatially relative descriptors used herein will be interpreted accordingly. Similarly, terms such as "upper," "lower," "vertical," "horizontal," etc. are used herein for descriptive purposes only, unless otherwise noted.

[0070]

[0086] In this specification, the terms "first" and "second" may be used to describe various features / elements (including steps), but these features / elements should not be limited by these terms unless the context dictates otherwise. These terms may be used to distinguish one feature / element from another. Thus, a first feature / element described below could be referred to as a second feature / element, and similarly, a second feature / element described below could be referred to as a first feature / element, without departing from the teachings of the present invention.

[0071]

[0087] Throughout this specification and the claims that follow, unless the context requires otherwise, the word "comprise," and variations such as "comprises" and "comprising," refer to various components that can be used together in methods and articles (e.g., compositions and apparatuses that include devices and methods). For example, the term "comprising" will be understood to mean the inclusion of any specified element or step, but not the exclusion of other elements or steps.

[0072]

[0088] In general, any apparatus and methods described herein should be understood to be inclusive, although all or a subset of the components and / or steps may alternatively be expressed exclusively as "consisting of" or "consisting essentially of" various components, steps, subcomponents, or substeps.

[0073]

[0089] As used in this specification and claims, including in the examples, and unless otherwise expressly specified, all numbers can be read as if preceded by the word "about" or "approximately," even if that term does not explicitly appear. The phrase "about" or "approximately," when describing a size and / or location, may be used to indicate that the described value and / or location is within a reasonable expected range of value and / or location. For example, a numerical value may have a value that is + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), + / - 10% of the stated value (or range of values), etc. Additionally, any numerical value provided herein should be understood to include about or approximately that value, unless the context dictates otherwise. For example, if the value "10" is disclosed, "about 10" is also disclosed. Any numerical ranges referred to herein are intended to include all subranges contained therein. It is also understood that when a value is disclosed, "less than or equal to" that value, "greater than or equal to" that value, and possible ranges between values ​​are also disclosed, as would be appropriately understood by one of ordinary skill in the art. For example, if a value "X" is disclosed, "less than or equal to X" and "greater than or equal to X" (e.g., X is a numeric value) are also disclosed. It is also understood that throughout the application, data is provided in several different formats, and this data represents endpoints and starting points, and may range between any combination of data points. For example, when a specific data point "10" and a specific data point "15" are disclosed, it is understood that not only values ​​between 10 and 15 are disclosed, but also values ​​greater than, greater than, less than, less than, less than, and equal to 10 and 15, and values ​​greater than, equal to, and equal to 10 and 15 are disclosed. It is also understood that each unit between two specified units is disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0074]

[0090] While various exemplary embodiments have been described above, any of several modifications may be made to the various embodiments without departing from the scope of the claimed invention. For example, the order in which the various described method steps are performed may often be changed in alternative embodiments, and one or more method steps may be omitted entirely in other alternative embodiments. Optional features of the various device and system embodiments may be included in some embodiments and not in other embodiments. Therefore, the above description has been provided primarily for illustrative purposes and should not be construed as limiting the scope of the claimed invention.

[0075]

[0091] The examples and illustrations contained herein indicate, by way of illustration, not limitation, specific embodiments in which the subject matter may be practiced. As noted above, other embodiments may be utilized and derived therefrom, such that structural and logical substitutions and changes may be made without departing from the scope of the present disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively under the term "invention" merely for convenience, and without any intention to intentionally limit the scope of the present application to a single invention or inventive concept when multiple inventions or inventive concepts are actually disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiment shown. The disclosure is intended to cover any and all adaptations or variations of the various embodiments. Combinations of the above embodiments, as well as other embodiments not specifically described herein, will be apparent to those skilled in the art upon reviewing the above description.

Claims

1. an upper rim having a second diameter; a lower rim having a first diameter and a bottom surface with at least one opening; a sidewall extending between the upper and lower rims; an arm having a first portion coupled to a central portion of the upper rim and the lower rim, and a second portion configured for connection to a positioning arm; a lumen in or along said arm that communicates with said at least one opening; Equipped with A docking device for intraocular surgery, wherein the first end of the upper rim and the second end of the upper rim define an opening of between 30 degrees and 180 degrees.

2. The device of claim 1 , wherein the first diameter is the same as the second diameter.

3. The device of claim 1 , wherein the first diameter is greater than a diameter of the limbus of the treated eye.

4. The device of claim 1 , wherein the first diameter is smaller than the second diameter.

5. 10. The device of claim 1, wherein the lower rim further comprises a lower surface having a curvature, profile, or durometer adapted and configured to be secured to the sclera and / or conjunctiva of a subject eye.

6. The device of claim 1 , wherein a lower surface of the upper rim is adapted and configured for releasable engagement with an upper surface of the lower rim.

7. The device of claim 1 , further comprising an opening between the central portion and the first end of the upper rim or between the central portion and the second end of the upper rim.

8. 8. The device of claim 1, further comprising a detachable coupling disposed between a location arm and an upper rim of the docking device, between an upper rim of the docking device and an upper portion of a side wall of the docking device, or between a lower rim of the docking device and a lower portion of a side wall of the docking device.

9. 1. A method of stabilizing a subject's eye during an ophthalmic surgical procedure, comprising: positioning a docking device having a lower surface with a suction ring on the subject's eye such that a central portion of the suction ring is at, above, or adjacent to the meniscus and caruncle of the subject's eye and an opening portion of the suction ring is opposite the central portion, the opening being in the range of 30 degrees to 180 degrees; applying a vacuum to the suction ring to secure a lower surface of the suction ring to a surface of the sclera and / or conjunctiva, the suction ring at least partially surrounding the cornea of ​​the eye; performing the ophthalmic surgical procedure on the subject's eye using a surgical instrument passed through the opening in the suction ring; A method comprising:

10. 10. The method of claim 9, further comprising hydrating the eye while the docking device is attached to the subject eye.

11. 10. The method of claim 9, further comprising manipulating a positioning arm of the ophthalmic imaging and illumination system prior to the positioning and applying vacuum steps so that the suction ring is aligned for use with the ophthalmic imaging and illumination system and for providing access to the subject's eye using the opening in the suction ring.

12. The method of claim 11 , further comprising the step of releasably coupling the docking device with the positioning arm prior to the step of manipulating the positioning arm.

13. 13. The method of claim 9, 11, or 12, wherein a release coupling is used to decouple the suction ring from the positioning arm upon movement of the patient's head during the ophthalmic surgical procedure.

14. 13. The method of claim 12, wherein the suction ring remains coupled to the subject's eye after activation of the detachable coupler.

15. 14. The method of claim 13, wherein the detachable coupling is between a location arm and an upper rim of the docking device, between an upper rim of the docking device and an upper portion of a sidewall of the docking device, or between a lower rim of the docking device and a lower portion of a sidewall of the docking device.

16. 12. The method of claim 11, further comprising hydrating the subject's eye using an eyewash system coupled to the positioning arm.

17. 1. A method for responding to a sudden event during an ophthalmic procedure using a docking system, comprising: positioning an ophthalmic docking system having a proximal suction ring over the patient's eye, the suction ring being attached to a rim, a support ring, a lower arm, and an upper arm of the ophthalmic docking system; receiving a sudden trigger event comprising one or more of: (i) movement of the patient's head or body; (ii) a malfunction of the ophthalmic docking system; and (iii) interference with the ophthalmic docking system; decoupling the ophthalmic docking system from the eye at one or more release points of the ophthalmic docking system distal to the suction ring, the one or more release points including an interface between (i) the rim and the suction ring, (ii) the support ring and the rim, and (iii) the lower arm and the support ring; A method comprising:

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