Non-contact wide-angle retinal viewing system

Abstract

A retinal viewing 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 set of focusing lenses that provide the microscope with a variable working distance or focal length. The disposable lens attachment includes an elastomer that has a proximal end connected to the optical head and a distal end connected to a high power / high diopter distal lens. The ECU executes instructions to view the retina or other intraocular anatomy of a patient's eye. The executing instructions cause the ECU to automatically adjust the variable working distance or focal length of the microscope while viewing an image of the retina through the distal lens.

Description

Background Technology

[0001] This disclosure relates to automated systems and methods for visualizing the retina and other anatomical structures of a patient's eye during ophthalmic surgery. The intraocular volume of the human eye is occupied by a transparent gel-like substance called the vitreous humor. The retina covers the posterior wall of the eye's internal cavity (i.e., the vitreous cavity), and a thin layer of interconnected neural tissue forms therein. Light entering the eye passes through the cornea and lens capsule, where the suspensory ligaments and ciliary muscles act on the lens capsule to focus the incoming light onto the retina. Individual rods and cones on the retina respond to the incoming light by generating nerve impulses, which are then interpreted by the brain as colors and images. Therefore, proper vision depends on a healthy retina and vitreous humor.

[0002] Factors such as injury, age, and severe myopia can cause vitreous detachment from the retina. The transient or persistent tension exerted by the detached vitreous on the retina can lead to a retinal tear. Similarly, blunt force to the area around the eye or head can directly damage the retina. To accurately diagnose retinal tears, vitreous detachment, and other intraocular conditions, clinicians typically use a high-resolution retinal observation system. This system illuminates the vitreous cavity with light from the harmless portion of the electromagnetic spectrum, subsequently revealing the illuminated anatomical structures at high magnification. In this way, clinicians can clearly observe the retina, macula, vitreous body, and other surrounding tissues. Similar levels of magnification and high-resolution observation can be used in preoperative and postoperative diagnostic settings. Summary of the Invention

[0003] This document discloses an improved retinal observation system and an accompanying method for observing the retina and other intraocular anatomical structures of the human eye. The system aims to provide a low-cost, non-contact, wide-angle retinal observation solution, eliminating the need for manual external focusing control of an accompanying ophthalmic microscope. Additionally, various aspects of this disclosure can utilize digital barcodes / serialization or another logic-based automated sequence to prevent unintentional reuse of disposable components of the retinal observation system, as described below.

[0004] A retinal observation system according to an exemplary embodiment includes an ophthalmic microscope with an optical head, a disposable lens attachment with a high-power / high-refractive-power 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, via magnetic attraction, hook-and-loop connection, adhesive, or direct mechanical engagement. The ECU, communicating with the microscope, is programmed to execute instructions to observe the retina or other intraocular anatomy during ophthalmic surgery through the manipulation of the distal lens and the microscope.

[0005] The ophthalmic microscope considered in this paper (which may be digital or analog in different embodiments) includes a set of internal focusing lenses that collectively provide the microscope with a variable working distance or focal length. This feature contrasts with typical ophthalmic microscopes characterized by a non-adjustable / fixed working distance, thus requiring lens reduction and manual intervention by the clinician in external focusing. The ECU automatically controls the focus setting of the internal focusing lenses when informed of the spatial position and focal length of the distal lens located at the distal end of the disposable lens attachment. In some embodiments, the ECU can perform this adjustment automatically, i.e., without clinician intervention or action, thus providing "autofocus" capability. This optional autofocus control occurs after the disposable lens attachment has been securely connected to the optical head. Alternatively, the ECU can act as a local controller that provides control input in response to control input from the clinician (e.g., operation of a foot pedal).

[0006] A method for controlling a retinal observation system during ophthalmic surgery on a patient's eye is also disclosed. According to an exemplary embodiment of the disclosed method, the method includes automatically verifying the connection between the proximal end of a disposable lens attachment and the optical head of an ophthalmic microscope in response to an ECU receiving a start signal. As described above, the microscope contemplated herein includes a set of internal focusing lenses that provide the microscope with a variable working distance or focal length. The distal end of the disposable lens attachment is connected to a high-power / high-refractive-power distal lens.

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

[0008] Disposable lens attachments in specific, non-restrictive configurations include a high-power / high-refractive-power distal lens with a refractive power of about 70 to about 110 diopters, and a conical elastomer. The proximal end of the elastomer is configured to connect to the optical head of an ophthalmic microscope, and the distal end of the elastomer connects to the distal lens. The conical elastomer is made of an elastic material configured to bend and / or collapse away from the patient's eye upon contact with the patient's eye.

[0009] The above-described features and advantages of this disclosure, as well as other possible features and advantages, will become apparent from the following detailed description of the best mode for carrying out this disclosure, taken in conjunction with the accompanying drawings. Attached Figure Description

[0010] Figure 1 This is a schematic diagram of an exemplary ophthalmic surgery performed according to the present disclosure using a retinal observation system with a disposable non-contact lens accessory device.

[0011] Figure 2 yes Figure 1 The diagram shows a retinal observation system.

[0012] Figure 3 Is it possible to... Figure 2 A schematic diagram of a telescopic and collapsible embodiment of a disposable non-contact lens accessory device used in conjunction with the system shown.

[0013] Figure 4 Is it possible to... Figure 1 and Figure 2 A schematic perspective view of an alternative embodiment of a disposable lens accessory device used with a retinal observation system.

[0014] Figure 5 It describes the use of Figure 2 A flowchart of a representative embodiment of a method for a retinal observation system. Detailed Implementation

[0015] This document describes embodiments of the present disclosure. However, it should be understood that the disclosed embodiments are merely examples, and other embodiments may take various alternative forms. The accompanying drawings are not necessarily drawn to scale. Some features may be exaggerated or minimized to show details of specific components. Therefore, the specific structural and functional details disclosed herein should not be construed as limiting, but rather as a representative basis for teaching those skilled in the art to employ the present disclosure in different ways.

[0016] In the following description, certain terms may be used for illustrative purposes only and are therefore not intended to be limiting. For example, terms such as “above” and “below” refer to directions referenced in the accompanying drawings. Terms such as “front,” “rear,” “before,” “after,” “left,” “right,” “rear,” and “side” describe the orientation and / or position of portions of a component or element within a consistent but arbitrary frame of reference, as will become clear from the text describing the component or element under discussion and the associated accompanying drawings. Furthermore, terms such as “first,” “second,” and “third” may be used to describe individual components. Such terms may include the words specifically mentioned above, their derivatives, and words with similar meanings.

[0017] Referring to the accompanying drawings, similar reference numerals refer to similar parts. Figure 1 The illustration schematically depicts a representative ophthalmic surgery 10, during which a clinician 12 needs precise visualization of the retina or other intraocular tissues within the eye 14 of a patient 140. For this purpose, the clinician 12 is aided by the high-definition, multi-dimensional digital observation capabilities of a retinal observation system 16, which is constructed and controlled as described herein. For clarity, Figure 1Only selected components of the retinal observation system 16 are depicted in the figure below. The retinal observation system 16 is described in more detail below with reference to the remaining figures.

[0018] See below for reference Figure 2 and Figure 3 The retinal observation system 16 utilizes the inherent internal focusing capability of the ophthalmic microscope 18 (e.g., a digital or analog medical-grade microscope) to provide a low-cost, disposable, non-contact option for wide-angle retinal observation. At least some of the incidental benefits of this teaching include... Figure 1 This exemplary ophthalmic surgery 10 provides high-power magnification without requiring clinician 12 to perform external focusing actions and without requiring a lens to reduce its size, or at least reduces clinician 12's reliance on such external focusing actions and hardware. (References) Figure 5 Specific control methods are disclosed to provide improved optical clarity, ease of use, and serialization / traceability.

[0019] In a representative embodiment, Figure 1 The ophthalmic surgery 10 depicted schematically may be a vitreoretinal surgery or any other surgery related to the diagnosis and treatment of diseases and / or injuries to the intraocular anatomy of the eye 14. By way of example, and not limitation, such surgery 10 may include directly repairing or reconnecting a torn or detached retina, performing a vitrectomy, and / or diagnosing and / or repairing a multitude of other possible conditions of the eye 14. Visualization of the target tissue during surgery 10 may be enhanced by real-time video broadcasting from a display monitor 11, such as a medical-grade 4K or other ultra-high-definition liquid crystal display (LCD) or organic light-emitting diode (OLED) panel, located in a position easily observable by the clinician 12 and other medical staff in the operating room.

[0020] In preparation for ophthalmic surgery 10, the patient 140 may be covered with a sterile surgical drape 20, which, or other covering, defines an opening 21 for exposing the eye 14. During surgery 10, the eye 14 may be held in an open position using a speculum 22 or other suitable tool. During the surgery, the clinician 12 may insert surgical instruments 23 into the vitreous cavity. Depending on the nature or specific stage of surgery 10, the surgical instruments 23 may be implemented differently as forceps, bladed vitrectomy probes, cannulas, infusion devices, endoscopes, or any other surgical instruments 23 that may be required.

[0021] As part of this method, the retinal observation system 16 is configured to provide real-time magnification and clear visualization of the intraocular anatomy of the eye 14 to assist clinicians 12 and other healthcare professionals in performing ophthalmic surgery 10. For this purpose, the ophthalmic microscope 18 of the retinal observation system 16 can be suspended overhead, for example, with a multi-axis robot 30 (see [link to documentation]). Figure 2The microscope 18 is connected to and / or supported by it. In order to function as intended with the retinal observation system 16 within the scope of this disclosure, the microscope 18 has a variable rather than fixed working distance, and therefore a variable or adjustable focal length. A working lamp 70, arranged on the bottom surface 29 of the microscope 18 or another suitable surface, can provide overhead illumination LL to further illuminate the eye 14 and the surrounding workspace.

[0022] Those skilled in the art will understand that current non-contact, wide-angle disposable retinal observation systems typically utilize a fixed-distance microscope and therefore rely on external focusing control at the attention of the clinician 12. For example, a rotary table or knob can be rotated manually or via a servo motor controlled by the surgeon to achieve proper focusing of the retina. The reducing lens used in such systems is typically positioned, for example, at a distance of 150 mm to 175 mm above the patient's cornea. Due to this fixed working distance, the reducing lens is moved via the clinician 12's manipulation of the aforementioned knob and / or operation of a foot switch to achieve the desired focusing of the retina.

[0023] In contrast, the retinal observation system 16 of this disclosure reduces and potentially eliminates the need for external focusing and the use of a reducing lens. This, in turn, eliminates potential problems that can sometimes be unstable and require additional dexterity and operating time. For example, embodiments of the disclosed retinal observation system 16 eliminate the aforementioned reducing lens and the need for external focusing, but the use of a reducing lens is not strictly excluded if a particular clinician 12 prefers to retain this option. Thus, performance advantages are provided by combining direct or indirect focusing control of a set of internal focusing lenses 18L of the ophthalmic microscope 18 with other aspects of the retinal observation system 16. That is, this method taps into and utilizes the focusing capabilities of the ophthalmic microscope 18, such as its digital embodiments, to provide a low-cost, disposable option for retinal observation, thereby greatly simplifying and enhancing vitreoretinal surgery.

[0024] Still referencing Figure 1 The retinal observation system 16 can be attached to the optical head 24 of the ophthalmic microscope 18 using mechanical coupling elements, for example... Figure 3 As described in the text, or attached to the optical head via attractive forces, such as magnetic attraction, hook and loop connections, friction / interference fits, or medical-grade adhesives, as... Figure 1 and Figure 2 As shown. Clinicians 12 and / or Figure 2The multi-axis robot 30 can adjust the spatial position and orientation of the microscope 18 relative to the corneal surface of the exposed eye 14. For clarity, the microscope 18 and the attached disposable lens attachment 25 are shown at a distance from the actual operating position, wherein the high-power / high-refractive-power distal lens 26 of the disposable lens attachment 25 is typically positioned approximately 5 mm–10 mm from the corneal surface of the eye 14. The need for precise and repeatable positioning of the distal lens 26 relative to the corneal surface is therefore suitable for the comprehensive precision focusing method of this disclosure, as referred to below. Figure 5 An exemplary method 100 for using the retinal observation system 16 will be described again.

[0025] In execution Figure 1 During an exemplary ophthalmic surgery 10, in some embodiments, the clinician 12 may choose to view other target areas of the retina or eye 14 through a set of optical eyepieces (not shown). As understood in the art, such eyepieces may be components of certain commercially available medical-grade ophthalmic microscopes to provide specific views to the clinician 12 or other healthcare professionals. Such non-limiting exemplary microscopes include those from Alcon, Inc. Revalia TM Ophthalmic microscopes, and OPMI from Carl Zeiss Meditec, Inc. 700. Other commercially available microscopes (such as, but not limited to, Aesculap, Inc.'s AEOS). TM Digital microscopes have abandoned the use of such eyepieces. Therefore, within the scope of this disclosure, the ophthalmic microscope 18 may or may not have an eyepiece in its construction.

[0026] Control surfaces may exist on a pair of control handles 118 of the ophthalmic microscope 18, one of such control handles 118 being... Figure 1 The angle is visible. This paddle-shaped control handle 118 can be alternatively configured as a cylindrical bicycle handlebar handle 218, such as... Figure 2 As shown, it can be configured into another suitable shape. Once the ophthalmic surgery 10 is completed, the disposable lens attachment 25 can be quickly and easily removed from the optical head 24 of the microscope 18 and discarded, thus providing the aforementioned low-cost disposable option. The small touchscreen 110 can also be used as... Figure 2 The electronic control unit (ECU 50) and / or the additional control input device of the microscope 18.

[0027] Regarding the high-power / high-refractive-power distal lens 26 used as an integral part of the disposable lens attachment 25, the term "high-power / high-refractive-power" refers to the magnification level suitable for the application. In a non-limiting example, a refractive power of at least 70 diopters may be desirable, with a range of approximately 70 to approximately 110 diopters likely being optimal for performing certain representative surgeries 10 (e.g., vitreoretinal surgery). In some embodiments, the distal lens 26 may be aspherical, but this shape is not strictly necessary. For example, the distal lens 26 may be spherical, in which case spherical aberration can be corrected by the ECU 50 using another lens, microscope 18, etc., in software.

[0028] As those skilled in the art will understand, the distal lens 26 is configured to optically reverse light from the posterior region of the vitreous cavity of the eye 14, where such light may be emitted from within the vitreous cavity via internal illumination. Thus, the distal lens 26 provides a virtual image of the retina and surrounding tissues. In some embodiments, light passing through the distal lens 26 propagates directly to the ophthalmic microscope 18, which has the benefit of eliminating the type of interventional retractor typically used with ophthalmic microscopes with a fixed working distance as described above. In other embodiments, an optional retractor 47 (see...) can be used. Figure 2 This option provides different or preferred views.

[0029] Regarding the variable working distance / focal length capability of the ophthalmic microscope 18 considered herein for use with the retinal observation system 16 of this disclosure, the internal focusing lens 18L provides a variable working distance, for example, from about 150 mm to 450 mm in a non-limiting representative embodiment. Ranges falling within these extreme values ​​can be used in other embodiments, such as 150 mm–300 mm or 150 mm–200 mm, wherein the automatic adjustment of the internal focusing lens 18L is directly or indirectly responsive to a focus control signal from the ECU 50 (arrow CC). 18 And so it happens, such as Figure 2 As shown and described below, microscope 18 is therefore directly focused on the virtual image produced by the distal lens 26.

[0030] The disposable lens attachment 25 is securely but temporarily connected to the optical head 24 of the ophthalmic microscope 18 via a connecting ring 34 located at its proximal end E1. For example, in Figure 1 and Figure 2In an exemplary embodiment, the disposable lens attachment 25 is constituted by an elastomer 28, which, in a representative configuration illustrated, is conical and forms a flexible and / or collapsible compliant support. In the event of accidental contact between the distal lens 26 and the eye 14, the elastomer 28 is configured to stretch, bend, or otherwise safely collapse away from the eye 14. That is, the elastomer 28 is highly flexible, bendable, and resilient, rather than rigid and inflexible. Possible constructions include soft, lightweight molded plastics or silicone rubber, perforated or mesh materials, or a network forming a horizontal and vertical interlaced suspension mesh, a thin disposable film, or other suitable constructions, as described below. Figure 3 Scalable configuration.

[0031] At the proximal end E1 of the disposable lens attachment 25, the connecting ring 34 can be potted or otherwise attached to the elastomer 28, for example, via a cured medical-grade adhesive material. The connecting ring 34 is configured to securely engage with the optical head 24 of the ophthalmic microscope 18, for example, via direct engagement (…). Figure 3 ) or solely through magnetism or other attractive forces ( Figure 1 and Figure 2 Possible alternatives to the attraction include the hooks and loops, adhesive materials, and friction / interference fits described above. This force can be used to provide the advantage of a simplified attachment and disconnection process, where the connection may be aided by structural alignment features on the microscope 18 and / or the connecting ring 34, which together allow the connecting ring 34 to be securely locked in place relative to the optical head 24.

[0032] At the distal end E2 of the disposable lens attachment 25, in stark contrast to the proximal end E1 / connecting ring 34, a small protective sleeve 32 made of opaque medical-grade polymer or metal material can be provided between the distal lens 26 and the elastomer 28 to help reduce glare on the distal lens 26 and promote a secure connection between the distal lens 26 and the elastomer 28. While other shapes and / or structural configurations of the elastomer 28 are possible within the scope of this disclosure, the described conical shape can help prevent dust or debris from falling onto the distal lens 26 from above, i.e., from the direction of the ophthalmic microscope 18.

[0033] Brief Reference Figure 3The elastomer 28 may optionally include a plurality of telescopic elastomers 280, namely elastomers 28A, 28B, and 28C. The elastomers 280 are configured to be hinged or pivoted to each other, and thus collapse away from the patient's eye when in contact with the patient's eye 14. That is, when the distal lens 26 is attached to the smallest diameter of the elastomers 280 (i.e., elastomer 28A), any contact with the eye 14 will cause elastomer 28A to move upward into the slightly larger diameter elastomer 28B, which in turn is telescopically pushed into elastomer 28C, as indicated by arrow DD. When not in contact with the eye 14, gravity will cause the elastomer 280 to return to its original position. Figure 3 The equilibrium position depicted in the image.

[0034] like Figure 4 As shown, Figure 1 The disposable lens attachment 25 can be alternatively implemented as a disposable lens attachment 125 having another elastomer 128. As shown, the elastomer 128 is a hinge mechanism having multiple hinged arm segments (shown as first arm segment 36 and second arm segment 136, respectively). The first arm segment 36 is configured to mechanically engage the optical head 24 of the ophthalmic microscope 18 at its proximal end E1, for example, via fastener 39 and sheet-like extension 38.

[0035] In the illustrated configuration, the first arm segment 36 defines a Y-shaped or forked end 37 that opens to receive a sheet-like extension 38 and a fastener 39. An additional fastener 45 connects a second arm segment 136 to the first arm segment 36, such that the fastener 45 forms a pivot point, allowing the second arm segment 136 to rotate about the axis of the fastener 45 to raise or lower the distal lens 26 located at the distal end E2. In this embodiment, a support 35, such as a cylindrical or generally conical metal or plastic, can be used to provide suitable mass for connecting the distal lens 26 and the protective sleeve 32 to the distal end E2.

[0036] Now for reference Figure 2 The ophthalmic microscope 18 described above can optionally be coupled to the end effector 31 of the multi-axis robot 30 briefly indicated above, wherein such coupling is indicated by a double-headed arrow CC. As understood, such a robot 30 typically includes a base 40 coupled to a set of wheels 41. To provide multi-degree-of-freedom motion, the robot 30 is equipped with a plurality of linkages 42, wherein each linkage 42 is interconnected via corresponding rotary joints 44. The base 40 can be coupled to the wheels 41 to facilitate repositioning or movement of the robot 30 within a facility or a specific operating room.

[0037] Therefore, within the construction of robot 30, each rotary joint 44 in some embodiments may be actively driven by a rotary actuator (not shown), such as a servo motor, to provide multiple degrees of freedom of control, including forward / backward, vertical and horizontal translation of end effector 31, as well as pitch, yaw, and roll orientation. Other embodiments may allow clinician 12 to passively reposition robot 30 without the assistance of such actuators. In general, the rotary joints 44 and the various linkages 42 allow end effector 31 and components of the retinal observation system 16 connected thereto to move or be moved within a defined workspace. In this way, robot 30 can facilitate precise positioning of distal lens 26 relative to the corneal surface 15 of eye 14, as indicated by arrows AA and BB.

[0038] like Figure 2 As shown, the motion control of the ophthalmic microscope 18 and the connected retinal observation system 16 can be achieved by... Figure 1 The clinician 12 uses various control inputs to give commands. For example, to command the robot 30 to position the optical head 24 in a specific orientation and spatial location in a three-dimensional Cartesian reference frame, the clinician 12 can depress the foot pedal 60 and / or activate a keyboard (not shown) on the control handles 118 or 218 mounted on the ophthalmic microscope 18, wherein the latter is configured in... Figure 2 As depicted in the image. Additional control inputs can be entered via the touchscreen 110.

[0039] In some embodiments, the software programming of robot 30 can automatically identify eye 14, for example, using machine vision algorithms, neural networks, proximity sensing, etc., and subsequently automatically locate and orient the retinal observation system 16, particularly its distal lens 26, at a predetermined distance from the corneal surface 15, typically a distance of about 5mm-10mm as understood in the art. Therefore, such software can communicate with the inherent control logic of ophthalmic microscope 18 to automatically adjust the working distance / focal length of its internal focusing lens 18L without intervention from clinician 12.

[0040] Additionally, using control input from the foot pedal 60, control handle 118 or 218 and / or the touchscreen 110 mounted near or on the retinal observation system 16, the clinician 12 is able to turn on the light 70 on the bottom surface 29 of the ophthalmic microscope 18 (see Figure 1 This allows the microscope 18 to emit the aforementioned beam LL, or automatically retracts the optical head 24 to a predetermined distance, for example, 50mm-75mm, and / or removes the retinal observation system 16 from the field of view when working on the anterior portion of the eye 14. When the clinician 12 is ready to return to the posterior view, the clinician 12 can simply move the retinal observation system 16 back to the appropriate position on the optical head 24, and thereafter use the same control inputs.

[0041] Using the aforementioned types of position sensing, machine vision, and / or artificial intelligence, the ophthalmic microscope 18, controlled by the ECU 50 in one respect, can automatically detect or otherwise determine that the retinal observation system 16 has been successfully mounted on the optical head 24. Machine vision can also be used to detect the attachment or detachment of the retinal observation system 16. In response, the ECU 50 can command the robot 30 to move the microscope 18 up or down, and / or position the distal lens 26 at a predetermined distance of 5mm-10mm above the cornea 15. Without requiring external focusing input or any other input from the clinician 12, as... Figure 5 As part of the method 100 shown, the optional autofocus control / adjustment of the internal focusing lens 18L via the ECU 50 can thus be used to obtain the correct focus, so that the clinician 12 is ready to participate in the operation.

[0042] The retinal observation system 16 disclosed herein is intended to be disposable and is therefore configured to be reusable. To this end, a serialization strategy can be enforced by the ECU 50 to prevent unintentional reuse of a given retinal observation system 16. This strategy can be driven by an existing CMOS or other camera of the ophthalmic microscope 18. For example, a scannable barcode, QR code, or other unique serial identification code 33 can be printed, affixed, or otherwise incorporated into the retinal observation system 16 and / or its sealed packaging (not shown) to record usage and prevent reuse. Exemplary locations for printing the serial identification code 33 include the surface of the connecting ring 34 or the protective sleeve 32, which, from a top view, provides a sufficiently wide and flat surface for printing or affixing a label containing the serial identification code 33. Other methods, such as RFID tags, may be used in other embodiments.

[0043] To achieve the various software-based control aspects of this disclosure, the ECU 50 is networked and communicates with the ophthalmic microscope 18 and the robot 30, wherein this bidirectional communication... Figure 3 The middle is marked by a double-headed arrow CC 30 The ECU 50 can be configured to execute computer-readable code or instructions implementing method 100 to perform one or more tasks involving the use of a retinal visualization system, wherein exemplary embodiments of method 100 are described in... Figure 5 As depicted in the diagram and described below. Although for simplicity of illustration, ECU 50 is schematically shown as a single device, ECU 50 may include one or more networked computer devices and associated computer-readable media or memory (M), including non-transitory (e.g., tangible) media involved in providing data / instructions that can be read by one or more processors (P).

[0044] The memory (M) can take many forms, including but not limited to non-volatile and volatile media. As will be understood, non-volatile media may include optical discs and / or magnetic disks, as well as other persistent memories, while volatile media may include dynamic random access memory (DRAM), static RAM (SRAM), etc., any or all of which 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 depicted but 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.

[0045] refer to Figure 5 The method 100 described in the exemplary embodiment may begin at sequence block B102, where the retinal observation system 16 is initialized. For example, a clinician 12 may turn on the robot 30 and the ophthalmic microscope 18 to... Figure 1 The ophthalmic surgery 10 shown is being prepared. Box B102 may require positioning the robot 30 and microscope 18 relative to the area to be operated by... Figure 1 The patient 140 occupies the operating position for rough automatic or manual positioning. Initialization allows the ECU 50 to receive a start signal (arrow CC). IN The ECU can ultimately respond by prompting the user to connect the disposable lens attachment 25 or 125 to the optical head 24, as described below. Method 100 proceeds to block B104 after initialization is complete.

[0046] In box B104, clinician 12 opens the sealed package containing the above-mentioned... Figures 1 to 3 Disposable lens accessory 25 or Figure 4 An alternative disposable lens accessory 125. As... Figure 5 As part of method 100, the packaging and / or disposable lens attachment 25 or 125 may include a unique serial identification code 33. In this embodiment, the clinician 12 may scan the serial identification code 33, thereby recording the usage of the disposable lens attachment 25 or 125 in memory (M) or a database. In a possible embodiment, the onboard CMOS camera or other onboard optical scanning capability of the ophthalmic microscope 18 may be used to scan the serial identification code 33 as a scan input, in which case the microscope 18 may transmit the scan input to the ECU 50, or the scan may be performed using an external scanning device. Method 100 then proceeds to block B106.

[0047] In block B106, ECU 50 compares the sequence identification code, which is the scan input from block B104, with a preloaded list of previously used identification codes. This list can be stored or pre-filled in the memory (M) of ECU 50, for example, in a lookup table. Each time clinician 12 opens and scans the corresponding sequence identification code 33 of the appropriate disposable lens accessory 25 or 125, the sequence identification code is recorded in memory (M) for later comparison. When the sequence identification code appears on the preloaded list, method 100 proceeds to block B108, and when the sequence identification code does not appear on the preloaded list, it proceeds to block B110.

[0048] In box B108, as a control action, ECU 50 can register / record an error code in memory (M) indicating that disposable lens attachment 25 or 125 has been previously used, and subsequently activate audio and / or visual indicators via ECU 50. That is, in response to recording the error code, ECU 50 can alert the clinician 12 that disposable lens attachment 25 or 125, or at least its associated serial identification code, has been previously used. For example, ECU 50 can illuminate a red light or other visual indicator, or it can... Figure 1 and Figure 2 The corresponding information is displayed on the display screens 11 and / or 110, and / or an audible alarm indicating that the disposable lens accessory 25 has been previously used is activated. Then, method 100 repeats box B104.

[0049] Box B110 includes confirmation of the scan results from box B104, for example, via ECU 50 recording a bit code indicating that the disposable lens attachments 25 or 125 have not been used previously, where this control action may immediately follow the confirmation signal. For example, ECU 50 may automatically activate audio and / or visual indicators as a control action, such as by illuminating a green light or displaying a monitor 11, touchscreen 110, and / or other visual indicator devices on a separate device. ECU 50 may also, in a corresponding... Figure 1 and Figure 2 The corresponding information is displayed on the display monitor 11 and / or touch screen 110, and / or an activation indication is made indicating that no sound chime or alert tone has been detected for previously used disposable lens accessories 25 or 125.

[0050] Therefore, frame B110 includes automatic verification of the correct connection between the proximal end E1 of the disposable lens attachment 25 or 125 and the optical head 24 of the ophthalmic microscope 18, for example, by using machine vision capabilities to identify accurate positioning and / or by receiving confirmation signals indicating a correct connection from the control panel (arrow CC). INThis confirmation will occur in conjunction with a code indicating that the disposable lens attachment 25 or 125 has not been used previously, wherein the control panel may include the aforementioned control handle 118 or 218, touchscreen 110, etc. The method 100 then proceeds to frame B112.

[0051] Box B112 requires the disposable lens attachment 25 or 125 to be connected to the optical head 24 of the ophthalmic microscope 18. Box B112 may include... Figure 1 and Figure 2 In this embodiment, the disposable lens attachment 25 is placed near the optical head 24 and allows magnetic attraction, hook-and-loop attraction, friction, or adhesion from the magnetic connecting ring 34 to hold the disposable lens attachment 25 in place. Figure 4 In an alternative embodiment, the disposable lens attachment 125 may be mechanically attached to the optical head 24. The method 100 then proceeds to frame B114.

[0052] Box B114 includes the start Figure 1 Ophthalmic surgery 10. In a possible embodiment, block B114 may include inputting a start signal to ECU 50, instructing clinician 12 to begin surgery 10. In response, ECU 50 may automatically command... Figure 2 The robot 30 positions the disposable lens attachment 25 or 125, especially its distal lens 26, at a distance from... Figure 2 At a predetermined distance of approximately 5mm-10mm from the corneal surface 15 of the eye 14 shown.

[0053] Once positioned in this manner, the ECU 50 can then adjust the variable working distance or focal length of the ophthalmic microscope 18 via direct autofocus control of the internal focusing lens 18L of the ophthalmic microscope 18, or via a motor drive response to input from the clinician 12. That is, the control response of the ECU 50 relative to the focus setting of the microscope 18 can occur entirely autonomously, or only in response to input signals from the clinician's input device (e.g., foot pedal 60, control handle 118 or 218, or touchscreen 110). This allows the clinician 12 to use the microscope 18 to view images of the retina or other intraocular structures of the patient's eye 14 through the distal lens 26. The method 100 then proceeds to frame B116.

[0054] In box B116, clinician 12 performs ophthalmic surgery 10 until it is completed. During surgery 10, inputs to ECU 50 can be made via... Figure 1 and Figure 2 Control handle 118 or 218, Figure 2 A touchscreen 110 and / or foot pedal 60 are provided, wherein the ECU 50 controls the position via the corresponding position control signal (arrow CC).30 The corresponding position control signal (arrow CC) is transmitted to robot 30, prompting a response. 30 When the data has been transferred to robot 30, method 100 proceeds to box B118.

[0055] Box B118 may include a function to determine whether ophthalmic surgery 10 is complete. For example, after surgery 10 is completed, ECU 50 may receive a completion signal. Figure 2 arrow CC COMP The ECU 50 instructs the clinician 12 to end surgery 10. In different embodiments, a completion signal may be generated when the clinician 12 touches the corresponding "End Surgery" icon on the display screen 110, or when the clinician 12 moves or commands the ophthalmic microscope 18 to move away from the patient 140 by a predetermined distance. In response to these two inputs, the ECU 50 may activate some or all of the rotation joints 44 of the robot 30 to assist in the repositioning of the ophthalmic microscope 18. The method 100 then proceeds to block B120.

[0056] In frame B120, the disposable lens attachment 25 or 125 needs to be removed from the optical head 24. The clinician 12 can then discard the disposable lens attachment 25 or 125. Then, method 100 is completed, and subsequent ophthalmic surgery 10 can be restarted in frame B102.

[0057] Therefore, the retinal observation system 16 described herein provides a low-cost, non-contact, wide-angle retinal observation option. This simplifies practicality by eliminating the need for external focusing from the ophthalmic microscope 18 by the surgeon 12. That is, by configuring the microscope 18 and programming the virtual image from the distal lens 26 within the variable working distance of the microscope 18 via the ECU 50, this solution eliminates the need for external focusing via an interventional reducing lens. As those skilled in the art will understand, eliminating the requirement for external focusing control reduces the time required for ophthalmic surgery 10. This, combined with the serialization strategy described above to prevent reuse, can further help reduce the overall risk of surgical complications. These and other incidental benefits will be readily understood by those skilled in the art in light of the foregoing disclosure.

[0058] The detailed descriptions and accompanying drawings are intended to be supportive and descriptive of this disclosure, but the scope of this disclosure is defined only by the claims. While some best modes and other embodiments for implementing the claimed disclosure have been described in detail, various alternative designs and embodiments exist to practice the disclosure as defined in the appended claims.

[0059] Furthermore, the features of the embodiments shown in the accompanying drawings or the various embodiments mentioned in this specification are not necessarily to be construed as embodiments independent of each other. Rather, each feature described in one of these examples of embodiments may be combined with one or more other desired features from other embodiments to produce other embodiments not described in words or with reference to the accompanying drawings. Therefore, such other embodiments fall within the scope of the appended claims.

Claims

1. A retinal observation system, comprising: An ophthalmic microscope having an optical head and a set of internal focusing lenses, the set of internal focusing lenses providing the ophthalmic microscope with a variable working distance or focal length; A disposable lens attachment having an elastomer and a high-power / high-refractive-power distal lens, wherein the elastomer is configured to collapse away from the patient's eye in response to contact with the patient's eye, the proximal end of the disposable lens attachment being connected to the optical head, and at the distal end of the disposable lens attachment, the elastomer being connected to the distal lens; as well as An electronic control unit (ECU) communicates with the ophthalmic microscope and is programmed to execute instructions for observing the retina of the patient's eye. The instructions are executed by the processor of the ECU to cause the ECU to focus the internal focusing lens autonomously or in response to an input signal from a clinician's input device, thereby adjusting the variable working distance or focal length of the ophthalmic microscope when observing an image of the retina through the distal lens.

2. The retinal observation system of claim 1, further comprising: A multi-axis robot that communicates with the ECU, wherein the processor executes the instructions to cause the multi-axis robot to automatically position the ophthalmic microscope such that the distal lens is moved away from the corneal surface of the patient's eye by a predetermined distance.

3. The retinal observation system as described in claim 1, wherein, The elastic body of the disposable lens accessory is conical.

4. The retinal observation system as described in claim 3, wherein, The elastomer includes a plurality of stretchable elastomers, which are collectively configured to collapse away from the patient's eye in response to contact with the patient's eye.

5. The retinal observation system as claimed in claim 1, wherein, The elastomer includes a plurality of articulated arm segments, including a first arm segment configured to mechanically engage with the optical head and a second arm segment having a distal end to which the distal lens is connected.

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

7. The retinal observation system as claimed in claim 1, wherein, The distal lens has a refractive power level of 70 to 110 diopters.

8. The retinal observation system as claimed in claim 1, wherein, The surface of the disposable lens accessory is printed with a unique serial number, which is configured to prevent the disposable lens accessory from being reused.

9. The retinal observation system as claimed in claim 8, wherein, To prevent the reuse of the disposable lens accessory, the ECU is configured to: Receive the scan input of the sequence identification code; and In response to the scan input matching a previously recorded sequence identification code, a control action is performed to prevent the reuse of the disposable lens accessory.

10. The retinal observation system as claimed in claim 9, wherein, The ophthalmic microscope is configured to automatically scan the sequence identification code to generate the scan input, and then transmit the scan input to the ECU.

11. A method for controlling a retinal observation system during ophthalmic surgery on a patient's eye, the method comprising: In response to receiving a start signal from the electronic control unit (ECU), the connection between the proximal end of the disposable lens attachment and the optical head of the ophthalmic microscope is automatically verified, including receiving a confirmation signal indicating the connection via the ECU. The ophthalmic microscope includes a set of internal focusing lenses that provide a variable working distance or focal length for the ophthalmic microscope, and the disposable lens attachment has an elastomer and a high-power / high-refractive power distal lens, wherein the elastomer is configured to collapse away from the patient's eye in response to contact with the patient's eye, and at the distal end of the disposable lens attachment, the elastomer is connected to the high-power / high-refractive power distal lens. as well as In response to verifying the proximal connection, the internal focusing lens is focused autonomously by the ECU or in response to an input signal from a clinician input device, and the variable working distance or focal length of the ophthalmic microscope is automatically adjusted, thereby allowing the ophthalmic microscope to observe an image of the patient's retina through the distal lens.

12. The method of claim 11, wherein, The ECU communicates with the multi-axis robot, and the method further includes the following when the ophthalmic microscope is coupled to the end effector of the multi-axis robot: The ECU transmits position control signals to the multi-axis robot to automatically position the ophthalmic microscope and the disposable lens attachment, so that the distal lens is 5 mm to 10 mm away from the corneal surface of the patient's eye.

13. The method of claim 11, wherein, Automatic verification of the proximal connection of the disposable lens accessory includes receiving the confirmation signal from the control panel.

14. The method of claim 11, wherein, The disposable lens accessory is printed with a unique serial number, and the method further includes: The ECU receives the scanned input of the unique serial number identifier; and In response to the scan input matching a previously recorded sequence identification code, a control action is performed, wherein the control action is designed to prevent the reuse of the disposable lens accessory.

15. The method of claim 14, further comprising: The identification code is scanned via the ophthalmic microscope to generate the scan input, and the scan input is then transmitted to the ECU.

16. The method of claim 14, wherein, Performing the control action includes registering or recording an error code in the memory of the ECU indicating that the disposable lens accessory has been used previously, and subsequently activating the audio and / or visual indicators via the ECU.

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