Non-contact wide-angle retinal observation system

Abstract

The retinal observation system and method of using the same includes an ophthalmic microscope, a disposable lens attachment, and an electronic control unit (ECU). The microscope has an optical head and an internal focusing lens set that provides the microscope with a variable working distance or focal length. The disposable lens attachment includes an elastic body having a proximal end that connects to the optical head and a distal end that connects to a high magnification / high diopter distal lens. The ECU executes instructions to observe the retina or other intraocular structures of a patient's eye. Execution of the instructions causes the ECU to automatically adjust the variable working distance or focal length of the microscope when observing an image of the retina through the distal lens.

Description

[Technical Field]

[0001] The present disclosure relates to automated systems and methods for visualizing the retina and other structures of a patient's eye when performing ophthalmic procedures. The intraocular volume of the human eye is occupied by a clear, gel-like substance called the vitreous. The retina lines the posterior wall of the eye's inner cavity, the vitreous cavity, thereby forming a thin layer of interconnected neural tissue. Light entering the eye passes through the cornea and lens capsule, and the zonules and ciliary muscles act on the lens capsule to focus the received light onto the retina. Individual rod and cone photoreceptor cells in the retina respond to the received light by generating nerve impulses, which are further interpreted by the brain as colors and images. Therefore, proper vision depends on a healthy retina and vitreous. [Background technology]

[0002] Factors such as trauma, age, and severe myopia can cause the vitreous to detach from the retina. The resulting transient or persistent tension on the retina by the detached vitreous can cause retinal tears. Similarly, blunt force of the head against the eye or surrounding area can directly damage the retina. To properly diagnose retinal tears, vitreous detachments, and other intraocular conditions, clinicians typically utilize high-resolution retinal viewing systems. Such systems illuminate the vitreous cavity with light in the eye-safe portion of the electromagnetic spectrum and then display the illuminated structures at high magnification. In this way, clinicians are provided with clear images of the retina, macula, vitreous, and other surrounding tissues. Similar magnification levels and high-resolution viewing can be used in pre- and post-operative diagnostic situations. Summary of the Invention [Means for solving the problem]

[0003] Disclosed herein are improved retinal observation systems and associated methods for observing the retina and other intraocular structures of the human eye. The systems are intended to provide a lower-cost, non-contact, wide-angle retinal observation solution that eliminates the requirement for manual external focus control of the associated ophthalmic microscope. Additionally, aspects of the present disclosure may employ digital barcoding / serialization or another logic-based automated sequence to prevent inadvertent reuse of single-use, disposable components of the retinal observation systems described below.

[0004] A retinal observation system according to an exemplary embodiment includes an ophthalmic microscope having an optical head, a disposable lens attachment having a high-magnification / high-diopter distal lens, and an electronic control unit (ECU). The proximal end of the disposable lens attachment is configured to connect to the optical head of the microscope, for example, by magnetic attraction, a hook-and-loop connection, adhesive, or direct mechanical engagement. The ECU, in communication with the microscope, is programmed to execute instructions for manipulating the distal lens and the microscope to observe the retina or other intraocular structures during an ophthalmic procedure.

[0005] The ophthalmic microscopes contemplated herein, which may be digital or analog in different embodiments, include a set of internally focusing lenses that collectively provide the microscope with a variable working distance or focal length. This feature contrasts with typical ophthalmic microscopes of the type characterized by a non-adjustable / fixed working distance and therefore requiring manual intervention by the clinician with a reduction lens and external focus adjustment actions. The ECU automatically controls the focus setting of the internally focusing lenses when notified of the spatial position and refractive power of the distal lens located at the distal end of the disposable lens attachment. In some embodiments, the ECU performs this adjustment automatically, i.e., without intervention or action by the clinician, thus providing an "autofocus" function. Any such autofocus control occurs after the disposable lens attachment is securely connected to the optical head. Alternatively, the ECU may function as a local controller, providing control input in response to control input from the clinician, such as the operation of a foot pedal.

[0006] Also disclosed is a method for controlling a retinal observation system during an ophthalmic procedure on a patient's eye. According to a disclosed exemplary embodiment, the method includes automatically verifying connection of a proximal end of a disposable lens attachment to an optical head of an ophthalmic microscope in response to receiving an initiation signal by an ECU. As noted above, the microscopes contemplated herein include an internally focusing lens set that provides the microscope with a variable working distance or focal length. The distal end of the disposable lens attachment is connected to a high magnification / high diopter distal lens.

[0007] In this embodiment and in response to confirming the proximal end connection, the ECU, either autonomously or in response to control input from the clinician, adjusts the variable working distance or focal length of the ophthalmic microscope, thereby using the microscope to observe an image of the retina of the patient's eye through the distal lens.

[0008] In certain non-limiting configurations, the disposable lens attachment includes a high power / high diopter distal lens having an optical power of about 70 diopters to about 110 diopters and a conical elastic body. The elastic body has a proximal end configured to connect to the optical head of an ophthalmic microscope and a distal end connected to the distal lens. The conical elastic body is composed of an elastic material configured to bend and / or fold away from the patient's eye when contacted with the patient's eye.

[0009] The above-mentioned features and advantages of the present disclosure, as well as other possible features and advantages, will become readily apparent from the following detailed description of the best mode for carrying out the disclosure, when read in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0010] [Figure 1] FIG. 1 is a schematic diagram of an exemplary ophthalmic procedure performed using a retinal viewing system constructed with a disposable non-contact lens attachment device according to the present disclosure. [Figure 2] FIG. 2 is a schematic diagram of the retinal observation system shown in FIG. [Figure 3] FIG. 3 is a schematic diagram of a nested, foldable embodiment of a disposable non-contact lens attachment device that can be used in the system shown in FIG. [Figure 4] FIG. 4 is a schematic perspective view of an alternative embodiment of a disposable lens attachment device that can be used in the retinal viewing system of FIGS. [Figure 5] FIG. 5 is a flowchart illustrating an exemplary embodiment of a method for using the retinal viewing system of FIG. DETAILED DESCRIPTION OF THE INVENTION

[0011] Embodiments of the present disclosure are described herein. However, it will be understood that the disclosed embodiments are merely exemplary, and that other embodiments may take various alternative forms. The figures are not necessarily drawn to scale. Some features may be exaggerated or minimized to show details of specific components. Therefore, specific structural and functional details disclosed herein should not be construed as limiting, but merely as a representative basis for teaching those skilled in the art how to employ the present disclosure in various ways.

[0012] In the following description, certain terms may be used for reference purposes only and, therefore, are not intended to be limiting. For example, terms such as "upper" and "lower" refer to directions within the referenced drawings. Terms such as "front," "rear," "forward," "rearward," "left," "right," "rear," and "side" describe the orientation and / or location of components or portions of elements within a consistent but arbitrary frame of reference that becomes clear by reference to the text and associated drawings that describe the components or elements being discussed. Furthermore, terms such as "first," "second," and "third" may be used to describe separate components. Such terms may include the terms specifically mentioned above, derivatives thereof, and words of similar import.

[0013] Referring to the drawings, in which like reference numbers refer to like components, a representative ophthalmic procedure 10 is shown generally in FIG. 1. During the ophthalmic procedure 10, a clinician 12 is required to accurately visualize the retina or other intraocular tissue within an eye 14 of a patient 140. To this end, the clinician 12 is aided by the high-resolution, multi-dimensional digital viewing capabilities of a retinal viewing system 16, which is constructed and controlled as described herein. For simplicity of explanation, only selected components of the retinal viewing system 16 are shown in FIG. 1, and the retinal viewing system 16 is described in more detail below with reference to the remaining figures.

[0014] As described below with reference to Figures 2 and 3, a retinal observation system 16 utilizes the resident internal focusing capabilities of an ophthalmic microscope 18, such as a digital or analog medical microscope, to provide a low-cost, disposable, non-contact option for wide-angle retinal observation. At least some of the attendant advantages of the present teachings include providing high magnification without the need for the clinician 12 to perform external focusing actions during the course of the exemplary ophthalmic procedure 10 of Figure 1, and without reduction lenses or at least reducing the clinician's 12 reliance on such external focusing actions and hardware. With reference to Figure 5, certain control techniques are disclosed herein to provide improved optical clarity, ease of use, and serialization / traceability.

[0015] In an exemplary embodiment, the ophthalmic procedure 10 shown schematically in FIG. 1 may be vitreoretinal surgery or any other procedure related to the diagnosis and treatment of disease and / or injury to intraocular structures of the eye 14. For example, and without limitation, such procedure 10 may include the direct repair or reattachment of a torn or detached retina, the performance of a vitrectomy, and / or the diagnosis and / or repair of various other possible conditions of the eye 14. Visualization of the target tissue during the course of the procedure 10 may be enhanced by real-time video broadcast via a display monitor 11, such as a medical-grade 4K or other ultra-high resolution liquid crystal display (LCD) or organic light-emitting diode (OLED) panel, located within easy view of the clinician 12 and other participating personnel in the operating room.

[0016] In preparation for the ophthalmic procedure 10, the patient 140 may be draped with a sterile surgical drape 20, which, or another covering, defines an opening 21 exposing the eye 14. A wire speculum 22 or other suitable instrument may be used to hold the eye 14 open during the procedure 10. The clinician 12 may insert procedure-specific surgical instruments 23 into the vitreous cavity during the procedure 10. Depending on the nature or particular stage of the procedure 10, the surgical instruments 23 may be variously embodied as forceps, a bladed vitrectomy probe, a cannula, an infusion instrument, an endoilluminator, or any other surgical instrument 23 that may be required.

[0017] As part of this procedure, the retinal observation system 16 is configured to provide real-time magnification and clear visualization of intraocular structures of the eye 14 to assist the clinician 12 and other participating personnel in performing the ophthalmic procedure 10. To this end, the ophthalmic microscope 18 of the retinal observation system 16 may be suspended overhead, for example, connected to and / or supported by a multi-axis robot 30 (see FIG. 2 ). To function as intended in a retinal observation system 16 within the scope of the present disclosure, the microscope 18 has a variable working distance, as opposed to a fixed working distance, and therefore a variable or adjustable focal length. Task lighting 70, located on the underside 29 of the microscope 18 or another suitable surface, may provide overhead lighting LL to further illuminate the eye 14 and surrounding workspace.

[0018] Those skilled in the art will appreciate that the present non-contact, wide-angle, disposable retinal viewing systems typically utilize a fixed-distance microscope and therefore rely on external focus control provided by the clinician 12. For example, a rotary dial or knob can be rotated manually or via a surgeon-controlled servo motor to properly focus the retina. The reduction lens used in such systems is typically positioned above the patient's cornea, e.g., 150 mm to 175 mm away. Because of the fixed working distance described above, the reduction lens is moved by the clinician 12 through manipulation of the knob and / or activation of a foot switch to achieve the desired focus on the retina.

[0019] In contrast, the disclosed retinal observation system 16 reduces and in some cases eliminates the need for external focus adjustment and reduction lenses, further eliminating potentially problematic features that can sometimes be unstable and require additional skill and operational time. For example, while the disclosed embodiments of the retinal observation system 16 eliminate the need for the reduction lens as well as its external focus adjustment, the use of a reduction lens is not strictly precluded if a particular clinician 12 prefers to retain this option. Thus, direct or indirect focus control of the set of internally focusing lenses 18L of the ophthalmic microscope 18 and integration with other aspects of the retinal observation system 16 provide performance advantages. That is, the present approach leverages and utilizes the focus adjustment capabilities of the ophthalmic microscope 18, e.g., digital embodiments thereof, to provide a lower-cost, disposable option for retinal observation that significantly simplifies and enhances vitreoretinal surgical procedures.

[0020] With further reference to FIG. 1 , the retinal observation system 16 may be attached to the optical head 24 of the ophthalmic microscope 18 using mechanical engagement elements as shown in FIG. 3 , or by attractive forces such as magnetic attraction, a hook-and-loop connection, a friction / interference fit, or a medical adhesive as shown in FIGS. 1 and 2 . The clinician 12 and / or the multi-axis robot 30 of FIG. 2 may adjust the spatial position and orientation of the microscope 18 relative to the exposed corneal surface of the eye 14. For simplicity of illustration, the microscope 18 and its associated disposable lens attachment 25 are shown significantly removed from their actual operating position, approximately 5 mm to 10 mm away from the corneal surface of the eye 14, where the high-power / high-diopter distal lens 26 of the disposable lens attachment 25 is typically positioned. Therefore, the need for precise and repeatable positioning of the distal lens 26 relative to the corneal surface lends itself to the integrated precision focusing approach of the present disclosure. An exemplary method 100 for using the retinal observation system 16 is described below, again with reference to FIG. 5 .

[0021] In the course of performing the exemplary ophthalmic procedure 10 of FIG. 1 , in some embodiments, the clinician 12 may choose to view the retina or other target area of the eye 14 through a set of optical eyepieces (not shown). As understood in the art, such eyepieces are an integral part of certain commercially available medical ophthalmic microscopes for providing specific images to the clinician 12 or other participating practitioner. Non-limiting exemplary microscopes in this category include the LuxOR® Revalia™ Ophthalmic Microscope from Alcon, Inc. and the OPMI Lumera® 700 from Carl Zeiss Meditec, Inc. Other commercially available microscopes, such as, but not necessarily limited to, the Aesculap AEOS™ Digital Microscope from Aesculap, Inc., dispense with the use of such eyepieces. Thus, eyepieces may or may not be present in the structure of an ophthalmic microscope 18 within the scope of this disclosure.

[0022] The control surfaces may be present on a pair of control handles 118 of the ophthalmic microscope 18, one of which is visible in the perspective view of FIG. 1. Such paddle-like control handles 118 may alternatively be configured as cylindrical bicycle-grip style handles 218 as shown in FIG. 2 or another suitable shape. Once the ophthalmic procedure 10 is complete, the disposable lens attachment 25 can be quickly and easily detached from the optical head 24 of the microscope 18 and discarded, thereby providing the low-cost disposable option described above. A small touchscreen 110 may also be used as an additional control input device for the electronic control unit (ECU 50) and / or microscope 18 of FIG. 2.

[0023] With respect to the high-power / high-diopter distal lens 26 used as an integral component of the disposable lens attachment 25, the term "high-power / high-diopter" refers to a level of power appropriate for the intended application. In a non-limiting example, a power of at least 70 diopters may be desirable, with a range of about 70 diopters to about 110 diopters sometimes being optimal for performing certain exemplary procedures 10, such as vitreoretinal surgery. While the distal lens 26 may be aspherical in some embodiments, this shape is not strictly required. For example, the distal lens 26 may be spherical, in which case spherical aberration may be corrected in software by the ECU 50 using another lens, microscope 18, or the like.

[0024] As will be appreciated by those skilled in the art, the distal lens 26 is configured to optically invert light from the posterior region of the vitreous cavity of the eye 14, optionally emitted from within the vitreous cavity by intraocular illumination. Thus, the distal lens 26 provides a virtual image of the retina and surrounding tissues. Light passing through the distal lens 26, in some embodiments, propagates directly to the ophthalmic microscope 18. This has the advantage of eliminating an intervening reduction lens of the type typically used in fixed working distance ophthalmic microscopes such as those described above. In other embodiments, an optional reduction lens 47 (see FIG. 2 ) may be used, with such options providing different or preferred fields of view.

[0025] With regard to the variable working distance / focal length capabilities of the ophthalmic microscope 18 contemplated herein for use in the retinal observation system 16 of the present disclosure, the internal focusing lens 18L provides a variable working distance, for example, from about 150 mm to 450 mm in a non-limiting exemplary embodiment. In other embodiments, ranges within these limits, such as 150 mm to 300 mm or 150 mm to 200 mm, may be used, and automatic adjustment of the internal focusing lens 18L is achieved by focus control (arrow CC) from the ECU 50, as shown in FIG. 2 and described below. 18 ) directly or indirectly in response to the image. Thus, microscope 18 focuses directly on the virtual image produced by distal lens 26.

[0026] The disposable lens attachment 25 securely but temporarily connects to the optical head 24 of the ophthalmic microscope 18 via a connecting ring 34 located at the proximal end E1 of the disposable lens attachment 25. In the exemplary embodiment of FIGS. 1 and 2, for example, the disposable lens attachment 25 is comprised of an elastic body 28. The elastic body 28, in the representative configuration shown, is conical in shape and forms a bendable and / or foldable elastic scaffold. In the event of inadvertent contact between the distal lens 26 and the eye 14, the elastic body 28 is configured to safely retract, bend, or otherwise fold away from the eye 14. That is, the elastic body 28 is highly flexible, bendable, and resilient, as opposed to being rigid and unbendable. Possible configurations include soft, lightweight molded plastic or silicone rubber, a porous or lattice-like material, or a network of alternating horizontal and vertical links forming a suspended net, a disposable membrane, or another suitable structure, as well as the nested configuration of FIG. 3, as described below.

[0027] At the proximal end E1 of the disposable lens attachment 25, the connecting ring 34 may be fitted into the elastic body 28 or may otherwise be connected, for example, by a curable medical adhesive material. The connecting ring 34 is configured to securely engage with the optical head 24 of the ophthalmic microscope 18, for example, by direct engagement ( FIG. 3 ) or simply by magnetic or other attractive forces ( FIGS. 1 and 2 ). Possible alternatives to magnetic or other attractive forces include hook-and-loop, adhesive materials, and friction / interference fits, as described above. Such forces may be effectively used to simplify the attachment and detachment process. The connection may be aided by structural alignment features on the microscope 18 and / or the connecting ring 34 that collectively enable the connecting ring 34 to be securely locked in place relative to the optical head 24.

[0028] At the distal end E2 of the disposable lens attachment 25, i.e., directly opposite the proximal end E1 / connection ring 34, a small protective sleeve 32 made of an opaque medical grade polymer or metal material may be positioned between the distal lens 26 and the elastomeric body 28 to help reduce glare on the distal lens 26 and facilitate secure connection of the distal lens 26 to the elastomeric body 28. While other shapes and / or structural configurations of the elastomeric body 28 are possible within the scope of the present disclosure, the conical shape shown may help prevent dust or debris from entering onto the distal lens 26 from above, i.e., from the direction of the ophthalmic microscope 18.

[0029] Referring briefly to FIG. 3 , the elastic body 28 may optionally include multiple nested elastic bodies 280, i.e., elastic bodies 28A, 28B, and 28C. The elastic bodies 280 are collectively configured to articulate or pivot relative to one another and thus fold away from the patient's eye 14 in response to contact with the patient's eye 14. That is, with the distal lens 26 attached to the smallest diameter of the elastic bodies 280, i.e., elastic body 28A, upon contact with the eye 14, elastic body 28A moves upward, as indicated by arrow DD, into the slightly larger diameter elastic body 28B, which in turn is forced to nest within elastic body 28C. When not in contact with the eye 14, gravity returns the elastic body 280 to the equilibrium position shown in FIG. 3 .

[0030] 4, the disposable lens attachment 25 of FIG. 1 may alternatively be embodied as a disposable lens attachment 125 having a separate elastic body 128. As shown, the elastic body 128 is an articulating mechanism having multiple hinged arm segments, shown respectively as a first arm segment 36 and a second arm segment 136. The first arm segment 36 is configured at a proximal end E1 to mechanically engage with the optical head 24 of the ophthalmic microscope 18 via, for example, a fastener 39 and a plate-like extension 38.

[0031] In the illustrated configuration, the first arm segment 36 defines a plate-like extension 38 and a Y-shaped or forked end 37 that opens to receive a fastener 39. An additional fastener 45 may connect the second arm segment 136 to the first arm segment 36 such that the fastener 45 forms a pivotal connection that allows the second arm segment 136 to rotate about the axis of the fastener 45 to raise or lower the distal lens 26 disposed at the distal end E2. In this embodiment, a cylindrical or generally conical metal or plastic support member 35 may be used to provide an appropriate mass for connecting the distal lens 26 and protective sleeve 32 to the distal end E2.

[0032] Referring now to FIG. 2 , the ophthalmic microscope 18 described above may optionally be coupled to the end effector 31 of the multi-axis robot 30 briefly described above. Such coupling is indicated by double arrow CC. As will be appreciated, such robots 30 typically include a base 40 connected to a set of wheels 41. To provide multiple degrees of freedom of movement, the robot 30 includes multiple linkages 42, with the various linkages 42 interconnected via corresponding revolute joints 44. The base 40 may be connected to the wheels 41 to facilitate relocation or movement of the robot 30 within a facility or a given operating room.

[0033] Thus, within the structure of the robot 30, each revolute joint 44 may, in some embodiments, be actively driven by a rotary actuator (not shown), e.g., a servo motor, to provide multiple degrees of control freedom, including forward / backward, vertical and horizontal movement, and pitch, yaw, and roll orientation of the end effector 31. Other embodiments may allow the clinician 12 to passively reposition the robot 30 without the assistance of such actuators. Collectively, the revolute joints 44 and various linkages 42 allow the end effector 31 and its connected components of the retinal observation system 16 to move or be moved within a defined workspace. In this manner, the robot 30 can facilitate precise positioning of the distal lens 26 relative to the corneal surface 15 of the eye 14, as indicated by arrows AA and BB.

[0034] As shown in Figure 2, motion control of the ophthalmic microscope 18 and its connected retinal observation system 16 can be commanded by the clinician 12 of Figure 1 using different control inputs. For example, to command the robot 30 to position the optical head 24 at a particular orientation and spatial location within a three-dimensional Cartesian coordinate system, the clinician 12 can press the foot pedal 60 and / or actuate a keypad (not shown) located on the control handle 118 or control handle 218 of the ophthalmic microscope 18, the latter configuration being shown in Figure 2. Further control inputs can be entered via the touchscreen 110.

[0035] The software programming of the robot 30, in some embodiments, can automatically identify the eye 14 using, for example, machine vision algorithms, neural networks, proximity sensing, etc., and then automatically position and orient the retinal observation system 16, and particularly its distal lens 26, at a predetermined distance, typically about 5-10 mm, from the corneal surface 15, as understood in the art. Such software can therefore communicate with the resident control logic of the ophthalmic microscope 18 to automatically adjust the working distance / focal length of its internal focusing lens 18L without requiring intervention by the clinician 12.

[0036] Additionally, using control inputs from the foot pedal 60, the control handle 118 or the control handle 218, and / or the touch screen 110 mounted near or on the retinal viewing system 16, the clinician 12 can turn on the illumination 70 (see FIG. 1 ) on the underside 29 of the ophthalmic microscope 18, causing the microscope 18 to emit the light beam LL described above, or can automatically retract the optical head 24 a predetermined distance, e.g., 50-75 mm, and / or remove the retinal viewing system 16 from view when working on the anterior portion of the eye 14. When the clinician 12 is ready to return to posterior viewing, the clinician 12 can simply return the retinal viewing system 16 to its predetermined position on the optical head 24 and then use the same control inputs.

[0037] At some point, the ophthalmic microscope 18, controlled via the ECU 50, may automatically detect or otherwise determine that the retinal observation system 16 is properly attached to the optical head 24 using position sensing, machine vision, and / or artificial intelligence of the types described above. Machine vision may similarly be used to detect that the retinal observation system 16 is attached or detached. In response, the ECU 50 may instruct the robot 30 to move the microscope 18 up or down and / or position the distal lens 26 a preset distance of 5-10 mm above the cornea 15. Thus, any automatic focus control / adjustment of the internal focusing lens 18L by the ECU 50 as part of the method 100 shown in FIG. 5 may be used to obtain proper focus so that the clinician 12 is ready for surgery, without requiring external focus adjustment input or any other input by the clinician 12.

[0038] The retinal observation systems 16 of the present disclosure are intended for single use and are therefore configured to be disposable. To this end, a serialization strategy can be implemented by the ECU 50 to prevent inadvertent reuse of a given retinal observation system 16. Such a strategy may be facilitated by the ophthalmic microscope 18's existing CMOS or other camera. To record use and prevent reuse, for example, a scannable barcode, QR code, or other unique serial identification code 33 may be printed, glued, or otherwise incorporated into the retinal observation system 16 and / or its sealed packaging (not shown). Exemplary locations for imprinting the serial identification code 33 include the surface of the connecting ring 34 or protective sleeve 32, which, when viewed from above, may provide a sufficiently large, flat surface for printing or attaching a label containing the serial identification code 33. In other embodiments, other approaches, such as RFID tags, may be used.

[0039] To enable the various software-based control aspects of the present disclosure, the ECU 50 is in network communication with the ophthalmic microscope 18 and the robot 30, and such bidirectional communication is indicated by the double arrow CC in FIG. 30 The ECU 50 may be configured to execute computer-readable code or instructions embodying a method 100 that performs one or more tasks involved in using a retinal visualization system. An exemplary embodiment of the method 100 is shown in FIG. 5 and described below. While the ECU 50 is shown generally as an integrated device for ease of illustration, the ECU 50 may include one or more networked computing devices along with associated computer-readable media or memory (M) that includes non-transitory (e.g., tangible) media involved in providing data / instructions that can be read by one or more processors (P).

[0040] The memory (M) may take many forms, including, but not limited to, non-volatile and volatile media. As will be appreciated, non-volatile media may include optical and / or magnetic disks and other persistent memory, while volatile media may include dynamic random access memory (DRAM), static RAM (SRAM), etc. Any or all of these may constitute main memory. Communication with the ophthalmic microscope 18 and the robot 30 may be achieved via a network connection to the input / output (I / O) circuitry of the ECU 50. Other hardware, not shown, but well established in the art, may be included as part of the ECU 50, including, but not limited to, local oscillators or high-speed clocks, signal buffers, digital signal filters, etc.

[0041] 5, the method 100 described above in the exemplary embodiment may begin sequentially in block B102 with initialization of the retinal observation system 16. For example, the clinician 12 may power on the robot 30 and the ophthalmic microscope 18 in preparation for the ophthalmic procedure 10 shown in FIG. 1. Block B102 may involve a coarse automatic or manual positioning of the robot 30 and the microscope 18 relative to the operating position occupied by the patient 140 of FIG. 1. Initialization initiates a start signal (indicated by arrow CC) by the ECU 50. IN ), to which ECU 50 may ultimately respond by prompting the connection of disposable lens attachment 25 or disposable lens attachment 125 to optical head 24, as described below. Method 100 proceeds to block B104 after initialization is complete.

[0042] In block B104, the clinician 12 opens a sealed package containing the disposable lens attachment 25 of FIGS. 1-3 or the alternative disposable lens attachment 125 of FIG. 4. As part of the method 100 of FIG. 5, the package and / or the disposable lens attachment 25 or 125 may include a unique serial identification code 33. In such an embodiment, the clinician 12 can scan the serial identification code 33, thereby recording the use of the disposable lens attachment 25 or disposable lens attachment 125 in memory (M) or a database. In possible embodiments, the built-in CMOS camera or other built-in optical scanning capability of the ophthalmic microscope 18 can be used to scan the serial identification code 33 as a scanning input (in which case the microscope 18 can transmit the scanning input to the ECU 50), or scanning can be accomplished using an external scanning device. The method 100 then proceeds to block B106.

[0043] In block B106, the ECU 50 compares the serial identification code as scanned in from block B104 with a preloaded list of previously used identification codes. Such a list may be stored or pre-populated in memory (M) of the ECU 50, for example, in a look-up table. Each time the clinician 12 opens and scans each serial identification code 33 of each disposable lens attachment 25 or disposable lens attachment 125, the serial identification code is recorded in memory (M) for later comparison. The method 100 proceeds to block B108 if the serial identification code appears on the preloaded list; alternatively, the method 100 proceeds to block B110 if the serial identification code does not appear on the preloaded list.

[0044] In block B108, as a control action, the ECU 50 may register / record in memory (M) an error code indicative of previous use of the disposable lens attachment 25 or the disposable lens attachment 125, and then activate an audio and / or visual indicator via the ECU 50. That is, in response to recording the error code, the ECU 50 may notify the clinician 12 that the disposable lens attachment 25 or the disposable lens attachment 125, or at least its associated serial identification code, has been previously used. For example, the ECU 50 may illuminate a red light or other visual indicator, or may display a corresponding message on the display screen 11 and / or the display screen 110 of FIGS. 1 and 2, and / or may activate an audio alarm indicating previous use of the disposable lens attachment 25. The method 100 then repeats block B104.

[0045] Block B110 includes verifying the results of the scan in block B104, for example, by recording via ECU 50 a bit code indicating no previous use of disposable lens attachment 25 or disposable lens attachment 125, with this control action optionally followed by a confirmation signal. For example, ECU 50 may automatically activate an audio and / or visual indicator as a control action, such as by illuminating a green light or other visual indicator device on display monitor 11, touchscreen 110, and / or a separate device. ECU 50 may also cause a corresponding message to be displayed on display monitor 11 and / or touchscreen 110, respectively, of FIGS. 1 and 2, and / or activate an audible chime or tone indicating that no previous use of disposable lens attachment 25 or disposable lens attachment 125 has been detected.

[0046] Therefore, block B110 may use, for example, machine vision capabilities to recognize the correct positioning and / or provide a confirmation signal (arrow CC) indicating proper connection. IN ) from a control panel, which may include the control handle 118 or 218, touch screen 110, or the like, described above. The method 100 then proceeds to block B112.

[0047] Block B112 entails connecting the disposable lens attachment 25 or disposable lens attachment 125 to the optical head 24 of the ophthalmic microscope 18. Block B112 may involve placing the disposable lens attachment 25 of the embodiment of Figures 1 and 2 adjacent to the optical head 24 and securing the disposable lens attachment 25 in place by magnetic attraction via the magnetic connector ring 34, or by hook-and-loop attraction, or by frictional or adhesive forces. In the alternative embodiment of Figure 4, the disposable lens attachment 125 may be mechanically coupled to the optical head 24. Method 100 then proceeds to block B114.

[0048] Block B114 includes initiating the ophthalmic procedure 10 of Figure 1. In possible embodiments, block B114 may include the clinician 12 inputting a start signal to the ECU 50 indicating that he or she wishes to begin the procedure 10. In response, the ECU 50 may automatically command the robot 30 of Figure 2 to position the disposable lens attachment 25 or the disposable lens attachment 125, and in particular its distal lens 26, at a predetermined distance of approximately 5-10 mm from the corneal surface 15 of the eye 14 shown in Figure 2.

[0049] Once so positioned, the ECU 50 can then adjust the variable working distance or focal length of the ophthalmic microscope 18 by direct autofocus control of its internal focusing lens 18L or by motorized response to input from the clinician 12. That is, the control response of the ECU 50 to the focus setting of the microscope 18 can occur completely autonomously or solely in response to input signals from a clinician input device, such as the foot pedal 60, the control handle 118 or 218, or the touchscreen 110. This allows the clinician 12 to view an image of the retina or other intraocular structures of the patient's eye 14 through the distal lens 26 using the microscope 18. The method 100 then proceeds to block B116.

[0050] In block B116, the clinician 12 performs the ophthalmic procedure 10 until it is completed. Inputs to the ECU 50 during the course of the procedure 10 may be provided via the control handle 118 or control handle 218 of FIGS. 1 and 2, respectively, the touch screen 110 of FIG. 2, and / or the foot pedal 60, etc., and the ECU 50 generates corresponding position control signals (arrows CC 30 ) to the robot 30. The method 100 then sends a corresponding position control signal (arrow CC 30 ) is sent to the robot 30, the process proceeds to block B118.

[0051] Block B118 may include determining whether the ophthalmic procedure 10 is complete. For example, once the procedure 10 is complete, the ECU 50 may generate a completion signal (arrow CC in FIG. 2 ) indicating that the clinician 12 wishes to end the procedure 10. COMP ) may be received. In various embodiments, generation of the completion signal may occur when the clinician 12 touches a corresponding "End of Treatment" icon on the display screen 110, or when the clinician 12 moves or commands the movement of the ophthalmic microscope 18 a predetermined distance away from the patient 140. In response to either input, the ECU 50 may actuate some or all of the revolute joints 44 of the robot 30 to assist in repositioning the ophthalmic microscope 18. The method 100 then proceeds to block B120.

[0052] Block B120 involves removing the disposable lens attachment 25 or disposable lens attachment 125 from the optical head 24. The clinician 12 can then discard the disposable lens attachment 25 or disposable lens attachment 125. The method 100 is then complete and begins anew at block B102 for a subsequent ophthalmic procedure 10.

[0053] Thus, the retinal observation system 16 described herein provides a lower-cost, non-contact, wide-angle retinal observation option. Eliminating the need for the surgeon 12 to externally focus the ophthalmic microscope 18 provides practical simplicity. That is, by configuring the microscope 18 to position the virtual image from the distal lens 26 within the microscope's 18 variable working distance and programming the ECU 50, the present solution eliminates the need for external focusing via intervention with a reduction lens. As will be appreciated by those skilled in the art, eliminating the requirement for external focus control reduces the length of the ophthalmic procedure 10. This, in conjunction with the anti-reuse serialization strategy described above, may further help reduce the overall risk of surgical complications. These and other ancillary benefits will be readily apparent to those skilled in the art in light of the above disclosure.

[0054] While the detailed description and drawings support and explain the present disclosure, the scope of the disclosure is defined only by the claims. Although some of the best modes and alternative embodiments for carrying out the claimed disclosure have been described in detail, there are various alternative designs and embodiments for carrying out the present disclosure as defined in the appended claims.

[0055] Furthermore, the features of the various embodiments shown in the drawings or described herein should not necessarily be understood as independent embodiments. Rather, each feature described in one example embodiment can be combined with one or more other desirable features of other embodiments, resulting in other embodiments not described or described by reference to the drawings. Accordingly, such other embodiments are encompassed within the scope of the appended claims.

Claims

1. 1. A retinal observation system comprising: an ophthalmic microscope having an optical head and an internal focusing lens set, the internal focusing lens set providing the ophthalmic microscope with a variable working distance or focal length; a disposable lens attachment having an elastic body and a high power / high diopter distal lens, the elastic body configured to fold away from the patient's eye in response to contact with the patient's eye, a proximal end of the disposable lens attachment connected to the optical head, and a distal end of the disposable lens attachment connected to the distal lens; an electronic control unit (ECU) in communication with the ophthalmic microscope and programmed to execute instructions for observing the retina of a patient's eye, wherein execution of the instructions by a processor of the ECU causes the ECU, either autonomously or in response to an input signal from a clinician input device, to focus the internal focusing lens, thereby adjusting the variable working distance or focal length of the ophthalmic microscope when observing an image of the retina through the distal lens; A retinal observation system comprising:

2. 2. The retinal observation system of claim 1, further comprising a multi-axis robot in communication with the ECU, wherein execution of the instructions by the processor causes the multi-axis robot to automatically position the ophthalmic microscope so that the distal lens is a predetermined distance away from the corneal surface of the patient's eye.

3. The retinal observation system of claim 1 , wherein the elastic body of the disposable lens attachment has a conical shape.

4. 4. The retinal observation system of claim 3, wherein the elastic body comprises a plurality of nested elastic bodies collectively configured to fold away from the patient's eye in response to contact with the patient's eye.

5. 2. The retinal observation system of claim 1, wherein the elastic body includes a plurality of hinged arm segments including a first arm segment configured to mechanically engage the optical head and a second arm segment having a distal end to which the distal lens is connected.

6. 2. The retinal observation system of claim 1, wherein the disposable lens attachment includes an attachment ring forming the proximal end of the elastic body, and the disposable lens attachment is magnetically connected to the optical head of the ophthalmic microscope.

7. The retinal observation system of claim 1 , wherein the distal lens has a power level between 70 diopters and 110 diopters.

8. 10. The retinal observation system of claim 1, wherein a surface of the disposable lens attachment is imprinted with a unique serial identification code configured to prevent reuse of the disposable lens attachment.

9. To prevent the reuse of the disposable lens attachment, the ECU: receiving a scan input of said serial identification code; and performing a control action to prevent said reuse of said disposable lens attachment in response to said scanned input matching a pre-recorded serial identification code. The retinal observation system of claim 8 , configured to:

10. 10. The retinal observation system of claim 9, wherein the ophthalmic microscope is configured to automatically scan the serial identification code to generate the scan input and thereafter transmit the scan input to the ECU.

11. 1. A method of controlling a retinal observation system during an ophthalmic procedure on a patient's eye, comprising: automatically confirming connection of a proximal end of a disposable lens attachment to an optical head of an ophthalmic microscope in response to receiving an initiation signal by an electronic control unit (ECU), the confirmation signal indicating the connection being received via the ECU, the ophthalmic microscope including an internally focusing lens set providing a variable working distance or focal length for the ophthalmic microscope, the distal end of the disposable lens attachment being connected to a high magnification / high diopter distal lens; and in response to verifying the connection of the proximal end, automatically adjusting the variable working distance or focal length of the ophthalmic microscope via the ECU, either autonomously or in response to an input signal from a clinician input device, thereby using the ophthalmic microscope to observe an image of the retina of the patient's eye through the distal lens. A method comprising:

12. The ECU is in communication with a multi-axis robot, and the method includes, while the ophthalmic microscope is coupled to an end effector of the multi-axis robot: automatically positioning the ophthalmic microscope and the disposable lens attachment via the ECU sending position control signals to the multi-axis robot so that the distal lens is 5 mm to 10 mm away from the corneal surface of the patient's eye. The method of claim 11 further comprising:

13. The method of claim 11 , wherein automatically verifying the connection of the proximal end of the disposable lens attachment includes receiving the verification signal from a control panel.

14. The disposable lens attachment is imprinted with a unique serial identification code, and the method comprises: receiving a scan input of the unique serial identification code via the ECU; performing a control action in response to the scan input matching a pre-recorded serial identification code, the control action being directed to preventing reuse of the disposable lens attachment; and The method of claim 11 further comprising:

15. 15. The method of claim 14, further comprising scanning the identification code through the ophthalmic microscope to generate the scanned input, and thereafter transmitting the scanned input to the ECU.

16. 15. The method of claim 14, wherein performing the control action includes registering or recording an error code in a memory of the ECU indicative of a previous use of the disposable lens attachment, and thereafter activating an audio and / or visual indicator via the ECU.

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