Patient interface for light adjustable intraocular lens irradiation system
By employing techniques such as mechanical connection and vacuum suction, the problem of decreased optical performance caused by LAL displacement was solved, achieving high-precision alignment between the LAL and the irradiation system, thus improving surgical outcomes and patient satisfaction.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- RXSIGHT INC
- Filing Date
- 2018-11-24
- Publication Date
- 2026-05-19
AI Technical Summary
The existing light-adjustable intraocular lens (LAL) is prone to displacement after surgery, leading to a decline in optical performance and affecting the patient's visual recovery. The existing alignment methods are not precise and stable enough, affecting the success rate of surgery and patient satisfaction.
By mechanically connecting the patient's eyeball to the irradiation system, the patient interface is used to align the beam intensity profile with the LAL, improving alignment accuracy. Techniques such as vacuum suction and mechanical engagement are used to ensure stable alignment between the LAL and the irradiation system.
This achieved high-precision alignment between the LAL and the irradiation system, improving the accuracy of optical property alterations and surgical outcomes, and enhancing the quality of patient vision recovery and satisfaction.
Smart Images
Figure CN111405865B_ABST
Abstract
Description
Technical Field
[0001] This patent document relates to an irradiation system for an optically adjustable lens. More specifically, it pertains to a patient interface for an optically adjustable intraocular irradiation system. Background Technology
[0002] Age-related cataracts commonly occur in the eyes of older adults. The current standard of care involves cataract surgery, which removes the opaque natural lens and implants an artificial intraocular lens (IOL) into the eye's capsular bag, restoring healthy vision. However, after surgery, the IOL can sometimes shift or deviate from its intended position within the capsular bag. This shift causes the IOL's focal point to deviate from its intended location, usually on the retina, leading to decreased optical performance. Furthermore, uncertainties in the eye's healing process, preoperative measurement errors, and mistakes in IOL selection and placement by the surgeon can also result in suboptimal surgical outcomes. This deterioration or reduction in optical performance often determines whether the patient needs glasses post-surgery and is therefore a key factor influencing postoperative patient satisfaction.
[0003] Mildly adjustable intraocular lenses (LALs) offer a solution to this problem. If patients are dissatisfied with the optical results during postoperative follow-up visits due to LAL misalignment, displacement, or suboptimal selection, doctors can alleviate their dissatisfaction by non-invasively adjusting the LAL's optical performance. Specifically, the doctor can diagnose the issue to determine the cause, nature, and extent of the poor LAL optical performance. Then, the doctor can calculate which changes in the LAL's optical properties can compensate for the deficiencies. Finally, the doctor can apply light to the LAL to induce the calculated changes.
[0004] This modulation is achieved by making the LAL (Liquid Atomical Light) from a photopolymerizable macromolecular material interspersed with photoinitiators. When a physician irradiates the LAL with a spatially modulated light source, typically emitting ultraviolet light, the photoinitiator absorbing the ultraviolet light induces photopolymerization of the macromolecules. The radial intensity profile of the selected irradiated UV light induces photopolymerization with a corresponding radial intensity profile. Photopolymerization with a radial profile alters the shape of the LAL, thereby changing its optical properties. Therefore, irradiating the LAL with an intensity profile modifies the LAL to achieve the optical properties calculated by the physician to compensate for performance deficiencies after LAL implantation. LAL systems and devices have been extensively described in U.S. Patent 6,450,642, "Lenses capable of post-fabrication power modification," co-owned by J. Jethmalani et al., the entirety of which is incorporated herein by reference.
[0005] Figure 1A -D schematically illustrates various aspects of the light modulation steps of the present invention. Figure 1A This means that when the LAL axis is aligned with the optical axis of the LAL irradiation system, the intensity profile of the UV beam is aligned with and centered with the LAL. Figure 1B This means that, under such alignment, the shape change caused by the UV beam in the LAL is aligned with and centered on the axis of the LAL.
[0006] Figure 1C This illustrates the case where the LAL is not aligned with the irradiation system, and therefore the LAL axis is not aligned with the irradiation system axis. In this situation, the intensity profile of the UV beam is not centered relative to the LAL axis. Figure 1D This explains that in such an misaligned LAL, the shape changes caused by the UV beam will be misaligned with the LAL axis. The optical properties and performance of an LAL with this misaligned shape change can differ significantly from the physician's calculations and plans. An LAL with misaligned shape changes typically cannot achieve the compensatory effect planned by the physician, thus failing to alleviate patient dissatisfaction. Therefore, aligning the LAL axis with the LAL irradiation system axis is crucial for the success of lens accommodation surgery and is a top priority in LAL irradiation system design.
[0007] In current LAL irradiation surgery, the surgeon manually fixes the LAL to align the eyeball and the LAL within it with the LAL irradiation system. While this is an effective method, this alignment may not be perfect; even slight tremors in the surgeon's hand can blur the irradiation pattern formed in the LAL. For these reasons, achieving better and more stable alignment between the LAL irradiation system and the LAL itself would further improve the visual outcomes of cataract surgery and increase patient satisfaction. Summary of the Invention
[0008] In an embodiment of the present invention, a light-adjustable intraocular lens irradiation system includes an irradiation source for generating a UV beam; an optical system for directing the UV beam toward a light-adjustable intraocular lens implanted in a patient's eye; and a patient interface coupled to the optical system for stabilizing the eye relative to the optical system to achieve alignment between the light-adjustable intraocular lens and the UV beam. Attached Figure Description
[0009] Figure 1A -D illustrates the alignment and misalignment of the light adjustment process.
[0010] Figure 2A -C illustrates an embodiment of a light-tunable lens irradiation system.
[0011] Figure 3A -C illustrates an embodiment of a light-tunable lens irradiation system.
[0012] Figure 4 A patient interface with vacuum suction is shown.
[0013] Figure 5A -B illustrates the two-piece patient interface.
[0014] Figure 6 A wearable embodiment of a light-adjustable lens irradiation system is shown. Detailed Implementation
[0015] The embodiments of the present invention address the aforementioned medical needs. In particular, these embodiments improve the alignment of the implanted light-adjustable lens (LAL) with the LAL irradiation system.
[0016] This embodiment achieves improved alignment by mechanically connecting the patient's eye to the irradiation system, thereby aligning the beam intensity profile with the LAL within the patient's eye. This mechanical connection significantly improves the relative alignment accuracy between the LAL irradiation system, the irradiation beam, and the implanted LAL. The optical modulation process with a well-aligned beam results in more precise planned changes to the LAL's optical properties, and thus more effectively compensates for LAL performance deficiencies.
[0017] Figure 2A -C illustrates an embodiment of a light-adjustable lens irradiation system 100, which includes an irradiation source 110 for generating a UV beam; an optical system 120 for directing the UV beam to a light-adjustable intraocular lens 10, or simply a light-adjustable lens (LAL), implanted in a patient's eyeball 1; and a patient interface 130 coupled to the optical system 120 for stabilizing the eyeball 1 relative to the optical system 120 to achieve alignment of the light-adjustable intraocular lens 10 and the UV beam.
[0018] The irradiation source 110 can emit an ultraviolet beam with a wavelength of 320-400 nm. For example, a helium-cadmium (HeCd) laser operating at 325 nm, or a mercury (Hg) arc lamp with spectral filtering of the emission lines at 334 and 365 nm, can be used as the irradiation source 110. Other embodiments may include a triple-frequency laser diode-pumped solid-state YAG laser operating at 355 nm, an argon-ion laser operating in the 350-360 nm range, a discharge lamp, a broadband xenon lamp, a mercury lamp with spectral filtering, or a UV LED, or an LED array.
[0019] The optical system 120 can modulate the ultraviolet beam to achieve a radial intensity profile by employing a digital mirror device (DMD), a spatial light modulator (SLM), such as a liquid crystal display (LCD) or a deformable mirror.
[0020] In some embodiments, the optical system 120 may include a patient-facing objective lens 121 as the most distal optical element. In such an embodiment, the patient interface 130 may be coupled to the objective lens 121 of the optical system 120.
[0021] Figure 2A A side view of these embodiments of the light-adjustable lens (LAL) irradiation system 100 is shown. Some embodiments of the LAL irradiation system 100 may include a patient engagement frame 131. The patient engagement frame 131 may be mounted on a rigid base, such as an examination table, shared with the optical system 120. The patient may rest their head on the chin rest of the patient engagement frame 131 and press their forehead against the headband. The forces applied by the chin rest and headband may position and fix the patient's head relative to the optical system 120. Once the head is fixed, the patient interface 130 may be moved forward to engage and fix the eyeball 1 relative to the optical system 120.
[0022] Figure 2B Some details of the contact area between the patient interface 130 and the eyeball 1 are shown. The optical system 120 may include an adjuster 122 that can move the patient interface 130 to bridge the final air gap remaining between the patient interface 130 and the patient's eyeball 1 after it has been secured by the patient engagement frame 131. The physician can adjust the adjuster 122 to move the patient interface 130 forward until it mates with the cornea 5 of the eyeball 1. Many other options can provide this same mate functionality: the entire optical system 120 may be movable relative to its base, or the patient interface 130 may have a retractable, expandable component, or the patient engagement frame 131 may have its own adjuster 122.
[0023] The patient interface 130 may include the most distal contact lens 132 to form a clear optical interface with the cornea 5 of the eyeball 1. The contact lens 132 may have different hardness; it may be a hard vitreous or PMMA lens, or it may be a soft, hydrogel-like contact lens, similar to a disposable contact lens placed on the cornea 5 for vision correction.
[0024] The patient interface 130 may include an elastic skirt 133, which can effectively hold the eyeball 1 in place by axial mechanical pressure and lateral friction. The pressure and force of the patient interface 130 can prevent the eyeball 1 from rotating voluntarily or involuntarily.
[0025] Once the patient's head is secured by the patient contact frame 131 and the eyeball 1 is further secured or stabilized by the patient interface 130, the optical system 120 can direct the UV beam with high precision and alignment towards the light-adjustable lens 10 located in the capsule 7 of the eyeball 1. This alignment can be fine-tuned in various ways. Once the patient interface 130 has secured the eyeball 1, thereby securing the LAL 10 within the eyeball 1, a physician or automated alignment system can adjust the alignment of the UV beam by laterally and possibly axially adjusting the aiming system of the optical system 120. In other embodiments, the patient interface 130 may include a lateral adjustment member. In another embodiment, the patient engagement frame 131 may have a lateral adjustment member.
[0026] Figure 2C The LAL irradiation system 100 is shown in a perspective view. In some embodiments, the optical system 120 may include a binocular microscope 123, or an aiming optics system 123, which assists a physician in aligning and ultimately docking the patient interface 130 with the eyeball 1. The binocular microscope 123 may have any combination of various aiming and alignment systems. It may include various target illumination sources, eye fixation lights, and aiming patterns in its optical system, such as crosshairs, aiming circles, etc. The binocular microscope 123, or aiming optics system 123, may be analog or video / digital and may include one or more video screens or displays. It may also be a combination of analog and video / digital binocular microscopes 123. It may have its own optical path or may at least partially share the optical path of the optical system 120. This can be achieved, for example, by a beam splitter.
[0027] Figure 3A -C illustrates a relevant embodiment of the light-tunable lens irradiation system 100. This LAL irradiation system 100 is substantially similar to... Figure 2A -C is an embodiment. The difference is that the patient interface 130 is coupled or attached to the patient engagement frame 131, rather than the optical system 120. In some embodiments, after the patient's head is secured by the patient engagement frame 131, the adjuster 122 can advance the patient interface 130 to engage with the patient's eyeball 1. Such an embodiment secures the patient's head to the patient engagement frame 131 and secures the patient's eyeball 1 and its LAL 10 to the patient interface 130. Since the patient engagement frame 131 shares a rigid base with the optical system 120, securing and stabilizing the optically adjustable lens 10 relative to the patient engagement frame 131 also stabilizes the optically adjustable lens 10 relative to the optical system 120. Therefore, such an embodiment also allows for high-precision alignment of the UV beam generated by the optical system 120 with the optically adjustable lens 10.
[0028] Figure 4The strength of the coupling and mechanical connection between the patient interface 130 and the eyeball 1 is shown to be improved by including a vacuum pump 142 for generating vacuum suction in the LAL irradiation system 100; and a suction head 144 for coupling the vacuum pump 142 to the patient interface 130 to transmit vacuum suction via a fluid connection. The patient interface 130 may include an elastic skirt 133 annularly disposed around its periphery for applying vacuum suction to the eyeball 1 through one or more annular and concentric grooves to stabilize the eyeball 1. These grooves can uniformly distribute the vacuum suction around the annular area to generate an annularly distributed force, effectively securing the eyeball 1 and the patient interface 130 together, thereby fixing the eyeball 1 in place.
[0029] In other embodiments, the patient interface 130 may include a mechanical engagement portion for enhancing the mechanical engagement force on the eyeball 1. This mechanical engagement portion may include protrusions, sharpened edges, constricting members, or friction-enhancing members. These protrusions, or edges, concentrate force on a small target area of the cornea 5, or a smaller target area of the sclera further out. These protrusions can reversibly press into the cornea 5, thereby improving the stability and immobility of the eyeball 1.
[0030] In some embodiments of the light-adjustable lens irradiation system 100, the patient interface 130 may be an integrated patient interface 130. Such an integrated patient interface 130 can be coupled to both the optical system 120 and the patient's eyeball 1. However, in practice, doctors sometimes find it challenging to align the eyeball 1 with the integrated patient interface 130 and dock it in one step. Patients sometimes have an instinctive reaction when the patient interface moves toward their eyeball. For doctors, moving the patient interface 130 in response to eye movement is challenging because the adjuster 122 may only be able to adjust the position of the patient interface 130 within a limited range. Moreover, the surface of the eyeball 1 is slippery, and the surface of the eyeball 1 may rotate away during docking attempts. Such reactions may lead to docking failure, or off-center, misaligned docking. Sometimes, doctors may need to attempt to successfully dock the patient interface 130, which can be frustrating for all involved.
[0031] Figure 5A -B illustrates an embodiment of a two-piece patient interface 130 that can improve docking success rates. The illustrated two-piece patient interface 130 divides docking into two stages. The two-piece patient interface 130 may include a device docking portion 134 configured to dock with an optical system 120, and an eye control portion 135 configured to couple to the patient's eyeball 1. The device docking portion 134 and the eye control portion 135 may be configured to couple together to form the complete two-piece patient interface 130.
[0032] In practice, a physician can first connect the device docking portion 134 to the distal end of the optical system 120, such as to its objective lens 121. The physician can then independently manipulate the eye control portion 135 to align and dock with the eyeball 1. Because the eye control portion 135 is not coupled to the optical system 120, these manipulations can be performed freely over a much wider range than the position that the adjuster 122 can adjust in the integrated patient interface 130. Therefore, the success rate of docking the eye control portion 135 can be very high.
[0033] After docking with the eyeball 1, the doctor can slowly move the docked eye control portion 135 toward the device docking portion 134. With sufficient care, the docking connection with the eyeball 1 can be maintained, allowing the eyeball 1 and its internal light-adjusting lens 10 to slowly align with the device docking portion 134 at the optical system 120. Finally, when the eye control portion 135 and the device docking portion 134 are properly aligned, the two portions can dock or couple to form a complete patient interface 130.
[0034] In some embodiments, the eye control portion 135 may include Figure 4 An embodiment of enhanced vacuum suction. Once the eyeball control portion 135 is mated with the eyeball 1, vacuum suction can be activated to increase the mating force that holds the eyeball control portion 135 and the eyeball 1 together. While sterilization requirements may prefer a disposable device mating portion 134, in some embodiments, the device mating portion 134 may be a permanent part of the optical system 120.
[0035] Figure 5B As shown in some other embodiments, the eye control portion 135 may include a clamping mechanism 136 for clamping the mechanical coupling with the eyeball 1 after an operator has established initial contact between the eye control portion 135 and the eyeball 1 at the patient interface 130. The clamping mechanism 136 can be any of a variety of embodiments. For example, it may include a tweezer-like claw driven by a finger-operated handle, as illustrated. A physician can apply force through the finger-operated handle to press or tighten the clamping mechanism 136 onto the eyeball.
[0036] Figure 6Some embodiments of the light-adjustable lenticule irradiation system 100 are shown, which can be very compact. A key aspect of this compactness is that it eliminates the possibility of using the binocular microscope 123 as a full-size microscope, as the size of the binocular microscope 123 is a significant factor forcing the overall form factor and scale of the light-adjustable lenticule irradiation system 100 to be considerable. For example, if in such an embodiment the function of the binocular microscope 123 is performed by a separate digital camera and display, the camera can be greatly miniaturized, thereby significantly reducing the form factor and scale of the entire LAL irradiation system 100.
[0037] In such an embodiment, the irradiation source 110, the optical system 120, and the patient interface 130 can be combined to form the wearable LAL irradiation system 100 shown. Such a wearable LAL irradiation system 100 may include a patient headband 137 to stabilize the wearable LAL irradiation system 100 relative to the patient's head.
[0038] While this document contains numerous specific contents, details, and numerical ranges, these should not be construed as limiting the scope of the invention and the claims, but rather as descriptions of specific features of particular embodiments of the invention. Some features described herein may also be implemented in combination in a single embodiment within the context of individual embodiments. Conversely, various features described in the context of a single embodiment may also be implemented individually or in any suitable sub-combination in multiple embodiments. Furthermore, although features may be described as acting on certain combinations, or even initially claimed to be so, in some cases, one or more features may be removed from the claimed combination, and the claimed combination may refer to another sub-combination or a variation of a sub-combination.
Claims
1. A light-tunable lens irradiation system, comprising: Irradiation light source, used to generate ultraviolet (UV) beams; An optical system for directing UV beams toward a light-adjustable intraocular lens (IOL) implanted in the patient’s eye. A patient engagement frame, mounted on a rigid base shared with the optical system, is used to fix the patient's head relative to the optical system; and The patient interface, operably fixed to the patient engagement frame, is used to stabilize the eyeball relative to the optical system to achieve light-adjustable alignment of the intraocular lens and UV beam. The optical system includes an objective lens, wherein the patient interface and the objective lens are spatially separated during the irradiation operation, and there is no intermediate component between the patient interface and the objective lens. as well as The objective lens can be adjusted axially.
2. The light-adjustable lens irradiation system according to claim 1, wherein, Light-adjustable lens irradiation systems are used to adjust the optical properties of the light-adjustable intraocular lens in the human eye after surgery. The patient interface was designed to be sized and configured to be directly coupled to the patient's eyeball. The optical system guides the UV beam to irradiate the central portion of the intraocular lens, and the optical system modulates the UV beam to achieve a radial intensity profile. The light-adjustable intraocular lens is made of photopolymerizable macromolecular materials with photoinitiators interspersed throughout. The radial intensity profile of the irradiated UV beam induces the polymerization of photopolymerizable macromolecular materials with corresponding radial profiles, and the polymerization with radial profiles alters the shape of the phototunable intraocular lens, thereby changing the optical properties of the phototunable intraocular lens.
3. The light-adjustable lens irradiation system according to claim 1, wherein, The optical system includes: a digital mirror device, Used to direct UV beams towards the eyeball, and Used to modulate UV beams to achieve radial intensity profiles.