专利摘要:
biradial patient interface. to improve the accuracy of ophthalmic surgical procedures by reducing corneal wrinkling, a patient interface for an ophthalmic system may include an attachment portion configured to secure the patient interface to a distal end of the ophthalmic system; a contact portion configured to engage the patient interface in an eye; and a contact element coupled to the contact portion configured to contact a surface of a cornea of the eye as part of the patient interface fitting in the eye and having a central portion with a central radius of curvature, rc, and a peripheral portion with a radius of peripheral curvature, rp, where rc is less than rp.
公开号:BR112015017803B1
申请号:R112015017803-0
申请日:2014-01-31
公开日:2022-01-11
发明作者:Tibor Juhasz;Ferenc Raksi;Ilya Goldshleger;Jeremy Dong;Wesley Lummis
申请人:Alcon, Inc.;
IPC主号:
专利说明:

CROSS REFERENCE TO RELATED ORDERS
[0001] This application claims priority pursuant to 35 U.S.C. §119 of US Patent Application Serial No. 13/757,236, filed February 1, 2013, the entire contents of which are incorporated herein by reference. BACKGROUND Field of Invention
[0002] This patent document relates to patient interfaces that attach an ophthalmic system to an eye for anterior segment ocular procedures. More particularly, this patent document relates to biradial patient interfaces that reduce a deformation of a cornea of the eye from the procedure. Description of Related Technique
[0003] This patent document describes examples and modalities of techniques and devices for attaching an ophthalmic system to an eye. The ophthalmic system may be an ophthalmic surgical laser system for performing an anterior segment ocular procedure, such as a cataract procedure. These devices are often referred to as patient interfaces. A patient interface serves to connect and couple the ophthalmic system and the patient's eye, so its performance is an important factor in controlling the accuracy and success of ophthalmic procedures. Therefore, improvements in patient interfaces can lead to improvements in the accuracy and reliability of ophthalmic procedures. SUMMARY
[0004] In summary and in general, embodiments of the present invention are capable of reducing corneal wrinkles, one of the factors that impede the accuracy of ophthalmic surgical procedures. Causes of corneal wrinkling include pressure exerted by the weight of the patient interface and an objective optical system in the eye; a compressive force generated by negative pressure from a suction system to immobilize the patient interface with respect to the eye; a mismatch between the radius of curvature of the patient interface and that of the cornea of the eye; the complex shape of the corneal surface; and varying the radius of curvature of the cornea from patient to patient.
[0005] To improve the accuracy of ophthalmic surgical procedures by reducing corneal wrinkling, a patient interface for an ophthalmic system in accordance with embodiments of the present invention may include an attachment portion configured to secure the patient interface to a distal end. of the ophthalmic system; a contact portion configured to engage the patient interface in an eye; and a contact element coupled to the contact portion configured to contact a surface of a cornea of the eye as part of the patient interface fit in the eye and having a central portion with a central radius of curvature, Rc, and a peripheral portion with a radius of peripheral curvature, Rp, where Rc is less than Rp.
[0006] Modalities of a method of fitting a patient interface of an ophthalmic surgical laser system into an eye may include: determining R (central cornea), a radius of curvature of a central portion of a cornea of the eye, and R (peripheral corneal sclera), a characteristic radius of curvature of a peripheral portion of the cornea and a sclera of the eye; select a contact element with a central portion having a central radius of curvature, Rc, and a peripheral portion having a peripheral radius of curvature Rp that is greater than Rc, where Rc is less than R (central cornea) + 1 mm and Rp is less than R (peripheral corneal sclera) + 1 mm; and fit the ophthalmic surgical laser system patient interface with the selected contact element in the eye. BRIEF DESCRIPTION OF THE DRAWINGS
[0007] FIG. 1 illustrates an ophthalmic surgical laser system.
[0008] FIGS. 2A-B illustrate corneal wrinkling during engagement with some patient interfaces.
[0009] FIG. 3 illustrates a one-piece patient interface with a biradial contact element.
[0010] FIG. 4 illustrates the two-piece patient interface with a biradial contact element.
[0011] FIG. 5 illustrates a method for using a patient interface with a biradial contact element. DETAILED DESCRIPTION
[0012] Some ocular laser surgical procedures, such as corneal refractive corrections, and laser-assisted photodisruptions and lens capsulotomies, may benefit from immobilizing the procedure eye to the ophthalmic surgical laser system during the procedure. Some ophthalmic surgical laser systems make use of a so-called patient interface to accomplish this task. A proximal portion of the patient interface may be attached to a distal end of the surgical laser system, such as its objective. A distal portion of the patient interface may include a contact lens. The patient interface can be fitted to the eye by pressing it to the eye and then applying suction to a space between the patient interface and the eye. When the patient interface is fitted to the eye, the contact lens is pressed against the cornea of the eye. Pressure and suction from the patient interface keep the eye constant relative to the surgical laser system, and the contact lens provides well-controlled optical coupling to the eye. Both of these attributes allow high-precision directing and focusing of the laser beam to predetermined target locations within the eye.
[0013] Some patient interfaces use flat contact lenses, also called applanation plates. Others include single-radius curved contact lenses. To prevent slipping and rolling of the eye caused by the tear film covering the eye slipping, these contact lenses are pressed against the cornea of the eye by mechanical forces and the application of suction by a vacuum system to a surrounding suction ring.
[0014] While the use of single bend radius contact lenses has the benefit of providing a well-defined and simple optical element to optimize the beam properties of the laser beam of the ophthalmic system and possibly a reference plane for directing the surgical laser accurately, its use can also lead to problems including the following.
[0015] (1) Bubbles are often dragged under the contact lens during fitting. To prevent this bubble formation, the radius of curvature of single radius of curvature contact lenses is typically chosen to be greater than that of the cornea. A typical corneal curvature radius in the central portion (in the central cornea) is in the range of 7.2 to 8.0 mm, very often close to 7.6 mm. Therefore, the radius of curvature of single-radius-curvature contact lenses is often chosen to be distinctly greater than these values, often in the range of 10 to 15 mm. The range of 10 to 15 mm for the radius of curvature can be useful for optimizing the wavefront of the laser beam 112 and minimizing its aberrations.
[0016] However, such a large non-coincidence of the radius of curvature of the contact lens and that of the cornea can lead to the problem that upon fitting the contact lens to the eye, it flattens and thereby wrinkles the surface of the cornea. These wrinkles can distort the laser beam, leading to high beam scattering and reducing its power below a photodisruption threshold, possibly making the important capsulotomy cuts of cataract surgery incomplete. If, in response, the power of the laser beam is increased to overcome the high scattering by wrinkles, then the higher power can damage the photosensitive tissues of the eye, such as the retina, especially when sweeping the beam through regions where cornea is not wrinkled. Wrinkling can also reduce the accuracy of laser beam steering.
[0017] (2) The use of single-radius curvature contact lenses can wrinkle the cornea for the additional reason that the front surface of the eye is more complex than that of the single-radius contact lens. It includes a central cornea with a radius of curvature R (central cornea) in the range of 7-8 mm, with a typical radius of curvature of about 7.6 mm. Surrounding the central cornea is a peripheral cornea, whose radius of curvature R (peripheral cornea) can gradually increase from 8 mm to 11 mm. Surrounding the peripheral cornea is the sclera, whose radius of curvature R (sclera) is markedly different from the central cornea: it is in the range of 9 to 14 mm, often in the range of 9.5 to 12 mm. A contact lens with a single radius of curvature and a front ocular surface that has two or even three distinct radii are mismatched to the degree that upon engagement with the patient interface in the eye, the mismatch can cause substantial wrinkling. of the cornea.
[0018] (3) The contact lens's mismatched radius of curvature and its unique radius of curvature structure not only can wrinkle the cornea, but also can cause internal deformation once the eye's inner lens support system it's very soft. Therefore, fitting a non-coincidental single radius of curvature contact lens typically shifts and tilts the eye lens with respect to the eye's optical axis. This displacement and tilt can make typical cataract surgery cuts, including the critical capsulotomy cut in the capsular bag and the cataract surgical cut pattern within the lens, off-center and distorted, leading to a deterioration of the optical results. of the cataract procedure.
[0019] For all these reasons, the development of new types of contact lenses that do not have a single radius of curvature structure and a non-coincident radius of curvature can improve the performance of ophthalmic surgical laser systems. Embodiments of the present invention offer solutions to the problems and challenges outlined herein.
[0020] FIG. 1 illustrates an image-guided ophthalmic surgical laser system 100. The surgical laser system 100 may include an ophthalmic laser 110 that can generate a surgical laser beam 112. The surgical laser beam 112 may be a pulsed beam with a length of pulse in the range of 1-1000 femtosecond. The laser beam 112 may be of sufficient power to photodisrupt an ophthalmic target tissue. The laser beam 112 can be coupled to an optic 120 via a beam splitter BS1. The optic 120 can focus and direct the laser beam 112 to a target point in a target region of a procedure eye 20 of a patient 10 through an objective 130. With the aid of scanning mirrors and actuators, the optic 120 also can sweep the laser beam 112 through a sequence of target points to cut eye tissue along a surgical cut pattern.
[0021] The procedure eye 20 may be immobilized with respect to the surgical laser system 100 with a patient interface 200 to prevent involuntary movements of the eye 20 and thereby enhance the accuracy and reliability of the surgical procedure. Patient interface (PI) 200, attached to objective 130 at a proximal end, can be attached to eye 20 with a vacuum suction system. To fit the PI 200 to the eye 20, the objective 130 can be aligned with the eye 20 by a gantry 132.
[0022] Surgical procedures may be aided by including various imaging systems in the surgical laser system 100. A video imaging system 140, such as a video microscope, may be included in the surgical laser system 100 which images the eye 20 and displays it on a video image display 144. In some embodiments, the video image system 140 may also include a video image processor 146 for processing the video image. Such video imaging systems 140 may provide a front view of the eye 20, but typically provide limited information on the depth or z-directional structure of the eye 20.
[0023] In order to provide depth or z-directional imaging, the surgical laser system 100 may include a depth imaging system 150. The depth imaging system 150 may include a coherence tomography imaging system. optics (OCT), a Scheimpflug imaging system, a slit lamp system or the like. Depth imaging system 150 may emit an imaging beam 152 which is coupled to optics 120 by a beam splitter BS2 and directed towards the target by optics 120. The imaging beam 152 may be reflected from eye 20 and returned to the system. depth imaging display 150, where it is analyzed and displayed on a depth image display 154. In some embodiments, a depth image processor 156 may be included to process the depth image so as to recognize edges and reduce noise. . In some surgical laser systems 100 the video imaging system 140 and the depth imaging system 150 may be coupled.
[0024] Finally, the surgical laser system 100 may also include a socket guidance system 160 for guiding the patient interface socket 200. The socket guidance system 160 may include a gantry controller 162 that can move the gantry 132 to align objective 130 with eye 20. In some embodiments, a fixation light source 164 may also be included to project a beam of fixation light 166 into a control eye 20c or eye 20 through objective 130. The Fixation light beam 166 can be adjusted to direct the patient to rotate their eyes to further improve alignment with the objective 130. Some of the operations of the guide system 160 can be computer controlled and can be based on the output of the image processor. video image 146 and depth image processor 156.
[0025] FIGS. 2A-B illustrate the engagement of patient interface 200 with eye 20 in more detail. The patient interface (PI) 200 may include an attachment portion 210 for attaching the PI 200 to the objective 130, a contact portion 220 that attaches to the eye 20, and a distal lens 230 that optically couples the surgical laser beam 112 and the imaging beams on a cornea 21 of the eye 20. The contact portion 220 may include a suction skirt or suction ring 222 which has a suction port 224. This suction port 224 may be coupled to a vacuum system or suction device to apply vacuum or negative pressure that expels air from a contact space 226, thereby pressing the distal lens 230 onto the cornea 21.
[0026] In an ideal operation, the laser beam 112 propagates through the optic 120, objective 130 and distal lens 230 to reach the target of the ophthalmic surgical procedure, such as a lens 22 of the eye, as a focused beam 112f and to form cuts precise surgeries. However, FIG. 2B illustrates that in some circumstances the snapping pressure can wrinkle the cornea 21. These wrinkles can spread the laser beam 112 into a scattered beam 112s that has lower power on the target and thus may be unable to perform the surgical cuts. Furthermore, the scattered laser beam 112s can be deflected or misdirected by the wrinkles. Lowered beam power and disorientation can have a number of negative consequences, as discussed earlier.
[0027] FIG. 3 illustrates a patient interface (PI) 300 in accordance with embodiments of the invention that is configured to reduce fit-related corneal wrinkling. Patient interface 300 may include an attachment portion 310 configured to secure patient interface 300 to a distal end of ophthalmic surgical laser system 100, in particular its objective 130. Attachment portion 310 may include a bayonet lock , a quick-fit latch or locking flanges, for example. It can be made of plastic or other flexible material.
[0028] The PI 300 may also include a contact portion 320 configured to engage the patient interface 300 with the eye 20. The contact portion 320 may include a suction skirt or suction ring 322 that has a suction port 324. The suction hole may be attachable to a vacuum or suction system that can apply negative pressure or suction to a contact space between the PI 300 and the cornea of the eye. With this design, the contact portion 320 can secure the PI 300 to the eye and thereby immobilize the eye 20 with respect to the surgical laser system 100. The PI 300 can also include a distal lens 330 that can optically couple the laser beam. laser 112 on the cornea in a controlled manner. Distal lens 330 can be a rigid or hard lens with well-defined optical characteristics.
[0029] In addition to these elements, the patient interface 300 may also include a contact element 340 which is coupled to the contact portion 320. The contact element 340 may be configured to contact a corneal surface as part of the socket of the cornea. 300 patient interface in the eye. Embodiments of the contact element 340 can reduce corneal wrinkling by having a different structure than existing contact lenses in that they can have two portions with different radii of curvature: a central portion 342 with a central radius of curvature Rc and a peripheral portion 344 with a radius of peripheral curvature Rp, where Rc is less than Rp. Such designs can have several advantages. (1) Structure Matching: Because of the additional design degree of freedom of having two radii instead of one, in general, the biradial structure of the contact element 340 can mirror and accommodate the complex front surface of the eye better than ray elements. single bend radius contact, thus reducing wrinkling compared to a single bend radius contact element. (2) Radius matching: In addition to the advantage of having a biradial structure in general, in some particular embodiments the radii Rc and Rp can be chosen to be close to the radius of curvature of the central cornea R (central cornea) and the radius of scleral curvature R (sclera), thus reducing the mismatch, flattening and wrinkling previously discussed. In some embodiments, Rc may be in the range of 6.6 mm to 9.1 mm and Rp in the range of 8.8 mm to 10.8 mm. In other embodiments, Rc may be in the range of 7.1 mm to 8.1 mm and Rp in the range of 9.3 mm to 10.3 mm. We recall here that the radius of curvature of the central cornea R (central cornea) is typically in the range of 7 and 8 mm, often close to 7.6 mm and the radius of curvature of the sclera R (sclera) is typically in the range of 9 to 14mm, often in the 9.5 to 12mm range. Therefore, the above-listed ranges of Rc and Rp can provide a close correspondence between the patient interface 300 and the central cornea 21 and sclera 24. Since from now on the structure of the cornea will be discussed in more detail and resolution, label 21 will refer only to the central cornea and label 23 to the peripheral cornea, as shown in FIG. 3.
[0030] It is noted here that rays from the frontal ocular surface have a wide distribution in various patient groups. A very small percentage of patients were identified with rays outside the above ranges: they constitute the tails of the ray distribution. Therefore, statements about ray ranges here refer to a range representative of the vast majority of the patient population and may not include the tail of the farthest percentile distribution.
[0031] Biradial patient interfaces whose radii roughly correspond to the radii of the central cornea and those of the sclera offer advantages over existing single-radius of curvature mismatched patient interfaces. Approximately matching the central radius of curvature Rc with that of the central cornea R (central cornea) can effectively reduce or even eliminate corneal wrinkling, as the engagement of the contact element 340 no longer exerts a flattening effect on the central cornea. . Furthermore, approximately matching the peripheral radius of curvature Rp with R (sclera) can allow effective suction and removal of bubbles formed during engagement along the contact surface between the peripheral portion 344 and the cornea. Bubble removal can be further facilitated and assisted by the application of lubricants to the contact surface.
[0032] Given the complex frontal surface of the eye, in some embodiments, Rp may not be combined with the radius of curvature of the sclera R (sclera) alone, but instead may be chosen to be characteristic of both the radius of curvature of the sclera R (sclera) peripheral cornea R (peripheral cornea) and the radius of curvature of the sclera R (sclera).
[0033] In the discussions above, Rc and Rp represent radii of curvature. The central portion 342 of the contact element 340 also has a lateral central diameter Dc. This lateral central diameter Dc is different from the radii of curvature: in a Cartesian coordinate system with its axis Z along the optical axis of the objective 130, the radii of curvature Rc and Rp are defined in an XZ or YZ plane, whereas the lateral center diameter Dc is defined in the XY plane. In addition, the peripheral portion 344 of the contact element may have a peripheral diameter Dp.
[0034] To discuss the relationship of Dc and Dp diameters to corneal diameters, it is recalled here that a central cornea diameter 21D (central cornea) can be in the range of 6 to 9 mm and a peripheral cornea diameter D ( peripheral) in the range of 10 to 12mm, often around 11mm D (peripheral cornea) is where the peripheral cornea 23 meets the sclera 24 and thus a relatively well defined amount. On the other hand, the radius of curvature of the cornea varies from its R value (central cornea) on the central cornea 21 somewhat gradually towards its R value (peripheral cornea) on the peripheral cornea 23. Therefore, the transition line between these portions may not be sharp and thus the value of D (central cornea) may depend on the particular definition adopted.
[0035] In light of these values, some corresponding embodiments of the contact element 340 may have a central diameter Dc in the range of 6 to 9 mm, in some cases in the range of 8 to 9 mm. Arrangements can also have a peripheral diameter Dp in 10 to 14mm.
[0036] For the completeness of the discussion, here we reproduce that R (central cornea) typically falls in the range of 7 to 8 mm, with an average value of about 7.6 mm; R (peripheral cornea) in the range of 8 to 11 mm; and R (sclera) in the range of 9 to 14 mm, often in the range of 9.5 to 12 mm.
[0037] Returning to the discussion of diameters, FIG. 3 illustrates that, in some embodiments, although the central diameter Dc of the contact element 340 can track the complex frontal ocular surface in general, but it cannot be accurately aligned or combined with either D (central cornea) or D (peripheral cornea) ). Instead, the center diameter Dc may fall between these values. Modalities with this feature can have an additional advantage in addition to (1) structure matching and (2) radius matching, as discussed below. (3) Lateral Stretch: As shown in FIG. 3 , in some embodiments an edge 346 may be formed at the central diameter Dc, where the central portion 342 and the peripheral portion 344 are joined, because the central radius, Rc, is different from the peripheral radius, Rp. In embodiments where D (central cornea) < Dc < D (peripheral cornea), upon engagement the edge 346 rests on the peripheral cornea 23. Since the radius of curvature of the central portion Rc is not equal to the radius of curvature of the peripheral cornea R (peripheral cornea), the contact element 340 at the edge 346 may not smoothly coincide with the peripheral cornea 23, but instead press or wedge into it as the engagement begins. As mating proceeds, this wedged edge 346 can laterally stretch the peripheral cornea 23, and thus the central cornea 21, in a "pull-out" direction the wrinkles that may have begun to form by snapping pressure. This is an additional advantage of the biradial design of the contact element 340 which is especially effective when the edge 346 with the central diameter Dc is greater than the diameter of the central cornea 21: D (central cornea) < Dc and smaller than the diameter of peripheral cornea D (peripheral cornea): Dc < D (peripheral cornea). As discussed above, for most eyes, D (central cornea) falls in the 6 to 9 mm range and D (peripheral cornea) in the 10 to 12 mm range, but the above inequality generally translates to Dc falling in the 10 to 12 mm range. 6 to 12mm. In some modalities Dc can fall in the range of 8 to 10 mm.
[0038] This stretching or stretching functionality can be especially effective if a contact element 340 is chosen for a patient who has a central radius of curvature Rc that is slightly smaller than the radius of curvature of the central cornea R (central cornea) of the patient.
[0039] To summarize the above considerations: 340 biradial contact elements can provide superior performance to existing contact lenses whose single-radius, mismatched radius of curvature design flattens and wrinkles the cornea, because contact element modalities Biradials described herein may offer one or more of (1) structure matching, (2) radius matching, and (3) lateral corneal stretching, all of these effects being capable of reducing corneal wrinkling.
[0040] Some embodiments of Contact Element 340 can go even further and match the structure of three portions of the anterior surface of the eye. In some embodiments, the contact element 340 may have a central portion with a central radius of curvature Rc in the range of 7 to 9mm to align with the central cornea 21, an intermediate portion with an intermediate radius of curvature Rc in the range of 8 to 9 mm. 12mm to align with the peripheral cornea 23 and a peripheral portion with a radius of peripheral curvature Rp in the range of 10 to 14mm to align with the sclera. In some embodiments these three rays are related as: Rc<Ri<Rp. Such a contact element, which corresponds to the structure of the frontal ocular surface and approaches its three rays, can cause even more limited corneal wrinkling. These patient interfaces and these contact elements can be called "triradials".
[0041] Furthermore, as discussed in (3) above, if one or both of the diameters separating the three regions of such a triradial contact element are not aligned with D (central cornea) and D (peripheral cornea), which can lead to to a beneficially intensified lateral stretching effect.
[0042] In some embodiments, the contact portion 320 may include an escape structure to aid in expulsion of air from the contact space between the contact element 340 and the cornea. This escape structure can take a variety of forms, such as radial channels or a rounded edge 346 along short arc segments.
[0043] The biradial structure of the contact element 340 has an additional aspect: during engagement of the biradial structure it can assist in centering the patient interface 300. In a case when the biradial contact element 340 makes its initial contact with the cornea in a position off-center, the rim 346 and the biradial contact surfaces can exert lateral forces that can move the eye laterally until it reaches a more centered position. This self-centering can also be made more effective if a lubricating liquid is applied to the mating surface.
[0044] In some embodiments, the distal lens 330 may be rigid or have reduced flexibility. The distal lens 330 can accommodate a proximal surface of the contact element 340, preventing more than 5% radial deformation of the contact element 340 upon engagement with the eye (ΔRc/Rc<5%). In some embodiments, this is accomplished by employing a distal lens 330 with a distal surface radius of curvature that is approximately matched to a proximal surface radius of curvature of the contact element 340.
[0045] In some embodiments, the contact portion 320 may include an attachment structure 350 for affixing the contact element 340 to the contact portion 320 along a perimeter. The fastening structure 350 can be configured to prevent lateral deformation of more than 5% of the contact element 340 upon engagement with the eye. To achieve this functionality, the fastening structure 350 may include a fastening slot, a support ring, an insertion structure, an interlocking structure, a sliding structure, a sliding structure, or a locking structure.
[0046] In some embodiments where the distal lens 330 can limit the radial deformation of the contact element 340 and the attachment structure 350 can limit its lateral expansion, the contact element 340 can be made of a soft material with low compressibility. in. An example might be a 340 contact element with a high water content. Such a contact element 340 can lubricate the contact surface well and can adjust its shape locally to a small degree to accommodate the corneal surface upon engagement, both factors reducing corneal wrinkling. At the same time, since the distal lens 330 and attachment structure 350 do not allow substantial radial or lateral deformations, such contact element 340 still retains its overall shape and radii, thus providing a known and well-controlled optical path for the laser beam 112, minimizing its astigmatism and distortions.
[0047] In the above embodiments, the contact element 340 may be manufactured to form part of the contact portion 320 and thus part of the patient interface 300. In other embodiments, the contact element 340 may be provided as a separate element. , for example, hydrated in a bag filled with an aqueous solution to prevent drying out. Such contact elements 340 may be configured to be inserted into the contact portion 320 during a preparatory stage of ophthalmic surgery by a surgeon or other qualified personnel. In such embodiments, the contact portion 320 may be configured to accept the insertion of the contact element 340.
[0048] The contact portion 320 can accommodate the insertion of the contact element 340 having an embodiment of the clamping structure 350 which may be a clamping groove, a support ring, an insert structure, an interlock structure, a structure sliding frame, a sliding frame or an interlocking frame. In either of these embodiments, the attachment structure 350 may be configured to firmly secure the contact element inserted into the contact portion and to prevent lateral expansion or bulging of more than 5% of the contact element upon engagement with the eye.
[0049] Further, in some embodiments, the contact portion 320 may include an embodiment of the rigid distal lens 330 having a distal surface with a distal radius of curvature within 5% of a proximal radius of curvature of a proximal surface of the element. contact element 340. In these embodiments, distal lens 330 can form extended contact with contact element 340 upon insertion and can prevent radial deformation of more than 5% of the contact element upon engagement with the eye. As discussed above, the contact element 340 may be flexible but has low compressibility, an example of which may be materials with a high water content.
[0050] Because of the delineated built-in geometry of the distal lens 330 and attachment structure 350 and because of its low compressibility, the contact element 340 is largely prevented from bending, deforming, stretching, compressing and bulging once inserted into contact portion 320, thereby retaining its shape to a high degree when fitted to the eye.
[0051] In these embodiments, although the contact element 340 may largely correspond with the structure and radii of the central cornea and that of the sclera, minor mismatches may remain as precise values of these radii vary from patient to patient. Therefore, when fitting the patient interface 300 to the eye, the central cornea 21 and contact element 340 may still need to deform to a small degree to accommodate these remaining small mismatches. As just outlined, in some embodiments, distal lens 330, attachment structure 350, and central radius of curvature Rc may be selected so that they largely prevent contact element 340 from deforming, stretching, and bending. Further, a material of the contact element 340 can be selected to make the compressibility of the contact element 340 low, thus preventing a compression of the contact element 340 as well. In such designs of the contact element 340, the central cornea 21 can deform to a considerably greater degree than the contact element 340 upon engagement. Numerically, a change in the central corneal radius of curvature R (central cornea) can be greater than a change in the central radius of curvature Rc of the contact element 340: AR(central cornea)>ΔRc. In other embodiments, the deformations of the central cornea can be substantially greater than the deformations of the contact element 340 upon engagement. The fit of these modalities can be characterized by ΔR (central cornea)>3ΔRc, ΔR (central cornea)>5ΔRc and in some modalities ΔR (central cornea)>10ΔRc.
[0052] The choice of material for the contact element 340 can play a role in ensuring the attributes described above. In some embodiments, contact element 340 may include a contact material that forms a lubricating film on the surface of the cornea. Lubrication may be effected by a surface of the contact element 340 which includes a hydrophilic material. Hydrophilic materials not only lubricate efficiently, they can also reduce fogging of the contact element 340, which could otherwise present a problem during mating.
[0053] One embodiment of the contact material of the contact element 340 may be hydrogel. Typically, the hydrogel may include a mixture of fluorosilicone and hydrophilic monomers. Various hydrogel modalities can have widely varying water content, have different lubricating and optical properties, and different compressibility. By some classifications, a hydrogel is termed as having low water content if the water content (by refractometer or by weight) is in the range of 10 to 50%, in some cases in the range of 3050%, medium if the water content is in the range of 50 to 70% and high if the water content is above 70%. The water content can be achieved and maintained by hydrating the contact element 340 in an aqueous solution, an example of which can be saline.
[0054] Once hydrated, the contact element 340 can have a hydrated refractive index in the range of 1.32 to 1.44, providing a close match to the corneal refractive index of about 1.37.
[0055] The higher the water content the more the contact element 340 is lubricating the contact surface with the central cornea 21, further reducing the causes of wrinkling.
[0056] FIG. 3 also shows that the contact portion 320 may include a suction ring or suction skirt 322 to be coupled to a suction system via a suction port 324, to receive a suction from the suction system and to apply the suction. from the suction system to a contact space between the patient interface 300 and the eye 20 to fit the patient interface 300 to the eye securely.
[0057] FIG. 3 also illustrates that in some embodiments of the patient interface 300, the attachment portion 310 and the contact portion 320 may be integrated portions of the patient interface 300. They may be tightly integrated during the manufacturing process, sometimes even formed from the same single plastic material.
[0058] FIG. 4 illustrates that in some other embodiments, the attachment portion 310 may be detached from the contact portion 320. In such embodiments, the freely movable contact portion 320 may first engage the eye 20 with ease. Once the eye 20 is captured by the contact portion 320, the contact portion 320 can be used to manipulate and align the eye 20 with the fixing portion 310 which is more difficult to move as it is attached to the system. hard-to-adjust ophthalmic laser 100. Once alignment is achieved, the contact portion 320 may be coupled to the clamp portion 310.
[0059] FIG. 5 illustrates a method 400 for engaging a patient interface in an eye. Method 400 may include the following steps. Step 410 may include determining R (central cornea), a radius of curvature of a central portion of a cornea, and R (sclera of the peripheral cornea), a radius of curvature characteristic of a peripheral portion of the cornea and a sclera of an eye of procedure. For example, R (peripheral corneal sclera) can be a value between R (peripheral cornea) and R (sclera) of the eye. Step 420 may include selecting a contact element with a central portion having a central radius of curvature, Rc, and a peripheral portion having a peripheral radius of curvature, Rp, which is greater than Rc. With respect to step 420, the contact element can be selected to have Rc less than R (central cornea) + 1.0 mm and Rp less than R (peripheral corneal sclera) + 1.0 mm. Finally, step 440 may include engaging the patient interface of an ophthalmic surgical laser system with the selected contact element in the eye. In some selection embodiments 420, the contact element can be selected to have Rc less than R (central cornea) + 0.75 mm and Rp less than R (peripheral corneal sclera) + 0.75 mm. In still other selection embodiments 420, the contact element may be selected to have Rc less than R (central cornea) + 0.5 mm and Rp less than R (peripheral corneal sclera) + 0.5 mm.
[0060] In the steps of method 400, the elements can be related to the analogous elements of the embodiments of FIGS. 1 to 4. In particular, the patient interface may be the patient interface 300, the procedure eye may be the eye 20, the contact element may be the contact element 340, and the ophthalmic surgical system may be the surgical system ophthalmic 100.
[0061] As described before, contact elements with the aforementioned characteristics may correspond to the biradial structure of the front surface of the eye. With the radii Rc and Rp in the ranges described, they can provide a correspondence to both the central cornea and the sclera. As also described above, the central and peripheral portions can meet at an edge which can have a stretching or stretching effect on the cornea, further reducing wrinkling. This stretching or stretching effect can be particularly effective if selection 420 includes a contact element with a central radius of curvature Rc less than R (central cornea).
[0062] Method 400 may further include inserting the selected contact element into the patient interface prior to docking, in embodiments where the contact element is provided separately from the patient interface. In some of these modalities, a manufacturer may provide a patient interface and a set of contact elements for the operating surgeon. After the surgeon has determined R (central cornea) and R (peripheral corneal sclera), she or he can select the contact element, whose central radius of curvature Rc and peripheral radius of curvature Rp are best suited to the light of the determined rays. R (central cornea) and R (peripheral corneal sclera) and thus promise the best to achieve the surgical goals.
[0063] In other embodiments, the contact element may be already installed or inserted into the patient interface during fabrication. In these embodiments, selection 420 may include selecting the patient interface from a set of patient interfaces that have the contact element selected.
[0064] In some embodiments of the method 400 the determination 410 may include generating a depth image of an anterior portion of the eye and determining R (central cornea) and R (peripheral corneal sclera) from the depth image. The depth image can be generated by an Optical Coherence Tomography (OCT) system, a Scheimpflug system, or a slit lamp.
[0065] Although this document contains many specifics, these should not be interpreted as limitations on the scope of the invention or what can be claimed, but rather as descriptions of specific features for particular embodiments of the invention. Certain features that are described in this document in the context of separate embodiments may also be implemented in combination in a single embodiment. Conversely, several features that are described in the context of a single embodiment may also be implemented in multiple embodiments separately or in any subcombination. Furthermore, although the features may be described above as acting in certain combinations and even initially claimed as such, one or more features of a claimed combination in some cases may be excised from the combination and the claimed combination may be directed to a sub-combination or variation. of a subcombination. In addition, variations and enhancements of the described implementations and other implementations can be made based on what is described.
权利要求:
Claims (23)
[0001]
1. Patient interface (200) for an ophthalmic system comprising: an attachment portion (210,310) configured to attach the patient interface to a distal end of the ophthalmic system; a contact portion (220,320) configured to engage the patient interface in an eye (20); and a contact element (340) coupled to the contact portion (220, 320), configured to contact a surface of a cornea of the eye as part of the patient interface fitting in the eye, and having a central portion (342) with a central radius of curvature, Rc, and a peripheral portion (344) having a peripheral radius of curvature, Rp, wherein Rc is less than Rp characterized in that the central portion (342) and peripheral portion (344) are joined at an edge (346) having a central diameter Dc; and Dc is less than a diameter of a peripheral corneal area (23) of the eye, wherein the diameter of the peripheral cornea is between 10-12 mm.
[0002]
2. Patient interface, according to claim 1, characterized in that Rc is in the range of 6.6 mm to 9.1 mm and Rp is in the range of 8.8 mm to 10.8 mm.
[0003]
3. Patient interface, according to claim 1, characterized in that Rc is in the range of 7.1 mm to 8.1 mm and Rp is in the range of 9.3 mm to 10.3 mm.
[0004]
4. Patient interface according to claim 1, characterized in that the contact portion comprises an escape structure (222) configured to assist in an expulsion of air from a contact space between the central portion (342) and the cornea.
[0005]
5. Patient interface according to claim 1, characterized in that it comprises: a rigid distal lens (330) configured to accommodate a proximal surface of the contact element (340), and to prevent radial deformation of more than 5% of the contact element by fitting in the eye; and an attachment structure (350) configured to affix the contact element (340) to the contact portion (320) along a perimeter and to prevent lateral expansion of more than 5% of the contact element upon engagement with the eye.
[0006]
6. Patient interface, according to claim 1, characterized in that: the contact element (340) is configured to be inserted into the contact portion (320); and the contact portion is configured to accept the insertion of the contact element.
[0007]
7. The patient interface of claim 6, wherein the contact portion comprises a rigid distal lens (330) having a distal surface with a distal radius of curvature within 5% of a proximal radius of curvature. of a proximal surface of the contact element, wherein the distal lens is configured to form extended contact with the contact element (340) upon insertion and to prevent radial deformation of more than 5% of the contact element upon engagement with the contact element. eye.
[0008]
8. Patient interface according to claim 6, characterized in that the contact portion (320) comprises an attachment structure (350) having at least one of an attachment slot, a support rim, a frame insert, an interlocking structure, a sliding structure, a sliding structure or a locking structure; wherein the attachment structure is configured to firmly secure the contact element (340) inserted into the contact portion (320), and to prevent lateral expansion of more than 5% of the contact element upon engagement with the eye.
[0009]
9. Patient interface according to claim 6, characterized in that a distal lens (330), an attachment structure (350), a contact element material (340) and the central radius of curvature Rc are selected so that upon fitting the patient interface to the eye, a change in a radius of curvature of an eye cornea is greater than a change in the central radius of curvature Rc: ΔR(central cornea)>Δ Rc.
[0010]
10. Patient interface, according to claim 1, characterized in that the contact element (340) comprises a contact material that forms a lubricating film on the surface of the cornea.
[0011]
11. Patient interface, according to claim 1, characterized in that a surface of the contact element (340) comprises a hydrophilic material.
[0012]
12. Patient interface, according to claim 1, characterized in that the contact element (340) comprises hydrogel with a water content above 70%.
[0013]
13. Patient interface, according to claim 1, characterized in that the contact element (340) comprises hydrogel with a water content in the range of 50 to 70%.
[0014]
14. Patient interface, according to claim 1, characterized in that the contact element (340) comprises hydrogel with a water content in the range of 30 to 50%.
[0015]
15. Patient interface, according to claim 1, characterized in that the contact element (340) has a hydrated refractive index in the range of 1.32 to 1.44.
[0016]
16. Patient interface, according to claim 1, characterized in that the contact portion (320) comprises: a suction ring (222,322) configured to be coupled to a suction system, to receive a suction from the system of suction, and for applying suction from the suction system to a contact space between the patient interface and the eye to engage the patient interface in the eye.
[0017]
17. Patient interface, according to claim 1, characterized in that the attachment portion (210,310) and the contact portion are integrated portions of the patient interface.
[0018]
18. Patient interface according to claim 1, characterized in that the attachment portion (210,310) is separate from the contact portion (320), and the attachment portion is configured to be coupled to the contact portion after the contact portion has been fitted to the eye.
[0019]
19. Patient interface, according to claim 1, characterized in that the contact element (340) comprises an intermediate portion between the central portion (342) and the peripheral portion (344) with an intermediate radius of curvature Ri , where Rc<Ri<Rp.
[0020]
20. Patient interface, according to claim 19, characterized in that Rc is in the range of 7 to 9 mm, Ri is in the range of 8 to 12 mm and Rp is in the range of 10 to 14 mm.
[0021]
21. Patient interface, according to claim 1, characterized in that Dc is greater than a diameter of a central corneal area (21) of the eye.
[0022]
22. Patient interface, according to claim 1, characterized in that the edge (346) is configured to contact the peripheral cornea area (23).
[0023]
23. Patient interface, according to claim 1, characterized in that the edge (346) is configured to stretch the central corneal area (21) of the eye during docking.
类似技术:
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同族专利:
公开号 | 公开日
ES2628643T3|2017-08-03|
US20180161201A1|2018-06-14|
MX2019006849A|2019-08-22|
RU2015136980A|2017-03-03|
BR112015017803A2|2017-07-11|
PL2922514T3|2017-09-29|
EP2922514A4|2016-01-13|
CN105120810B|2017-05-24|
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US20210015359A1|2021-01-21|
JP6997162B2|2022-01-17|
MX366084B|2019-06-27|
JP2016504964A|2016-02-18|
CA2896350A1|2014-08-07|
US20190269554A1|2019-09-05|
RU2666117C2|2018-09-05|
AU2014212237B2|2018-03-01|
KR20150112951A|2015-10-07|
KR102164566B1|2020-10-13|
JP6466854B2|2019-02-06|
JP6626178B2|2019-12-25|
CN105120810A|2015-12-02|
EP2922514B1|2017-05-03|
CA2896350C|2021-07-27|
MX2015009207A|2015-12-01|
US10335315B2|2019-07-02|
US20140216468A1|2014-08-07|
DK2922514T3|2017-08-21|
PT2922514T|2017-06-05|
JP2020028766A|2020-02-27|
TWI600419B|2017-10-01|
TW201440722A|2014-11-01|
JP2019058674A|2019-04-18|
AU2014212237A1|2015-08-06|
WO2014120990A1|2014-08-07|
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DE102020105335A1|2020-02-28|2021-09-02|Carl Zeiss Meditec Ag|SYSTEM, CONTACT DEVICE, AND METHOD OF MANUFACTURING A CONTACT DEVICE|
法律状态:
2018-11-13| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
2020-02-04| B25A| Requested transfer of rights approved|Owner name: ALCON, INC. (CH) |
2020-03-24| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
2021-11-03| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
2022-01-11| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 31/01/2014, OBSERVADAS AS CONDICOES LEGAIS. |
优先权:
申请号 | 申请日 | 专利标题
US13/757,236|2013-02-01|
US13/757,236|US10335315B2|2013-02-01|2013-02-01|Bi-radial patient interface|
PCT/US2014/013971|WO2014120990A1|2013-02-01|2014-01-31|Bi-radial patient interface|
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