US-12623407-B2 - Customized 3D printing lens design integrating visible-light optical coherence tomography

US12623407B2US 12623407 B2US12623407 B2US 12623407B2US-12623407-B2

Abstract

Provided herein are systems and methods for additive manufacture of a customized ocular contact lens for a subject in a fast and convenient manner. In various aspects disclosed herein, methods disclosed herein provide for the imaging of the outer surface of a subject's cornea, designing a customized ocular contact lens based on the data from the imaging of the cornea, including determining anterior and posterior surfaces of the ocular contact lens, manufacturing the ocular contact lens using additive manufacturing, verifying the fit of the customized ocular contact lens on the subject's cornea, and verifying the optical power of the customized ocular contact lens. These features allow for the fast and convenient production of an ocular contact lens customized to a subject's cornea and manufactured to a specified optical power.

Inventors

Pengpeng ZHANG
Raymond S. FANG
Cheng Sun
Hao F. Zhang

Assignees

NORTHWESTERN UNIVERSITY

Dates

Publication Date: 20260512
Application Date: 20240423

Claims (20)

1 . A method for additive manufacture of a customized ocular contact lens for a subject, the method comprising steps of: imaging and acquiring image data of an outer surface of a cornea of the subject using visible-light optical coherence tomography (vis-OCT); designing the customized ocular contact lens from the image data; wherein the step of designing comprises: processing the image data to generate a 3-D computational model of the outer surface of the cornea based on the acquired image data; determining a posterior surface of the customized ocular contact lens using the 3-D computational model; determining an anterior surface of the customized ocular contact lens to provide a selected optical power to the customized ocular contact lens; and generating a 3-D printable data set of the customized ocular contact lens comprising the determined posterior surface and the determined anterior surface; manufacturing the customized ocular contact lens using additive manufacturing based on the 3-D printable data set of the customized ocular contact lens; and verifying a shape of the manufactured customized ocular contact lens by imaging the anterior surface and the posterior surface of the manufactured customized ocular contact lens using visible-light optical coherence tomography.
2 . The method of claim 1 , wherein imaging the anterior surface and the posterior surface of the manufactured customized ocular contact lens comprises imaging the anterior surface and the posterior surface of the manufactured customized ocular contact lens when the manufactured customized ocular contact lens is wet.
3 . The method of claim 1 , wherein imaging the anterior surface and the posterior surface of the manufactured customized ocular contact lens comprises imaging the anterior surface and the posterior surface of the manufactured customized ocular contact lens when the manufactured customized ocular contact lens is suspended in a liquid, wherein the liquid is water, oil, or diluted intralipid.
4 . The method of claim 1 , wherein imaging the anterior surface and the posterior surface of the manufactured customized ocular contact lens comprises imaging the anterior surface and the posterior surface of the manufactured customized ocular contact lens when the manufactured customized ocular contact lens is positioned on and in contact with the cornea of the subject.
5 . The method of claim 1 , wherein at least one of the steps of processing the image data, determining the posterior surface, determining the anterior surface, generating the 3-D printable data set, and manufacturing the customized ocular contact lens is performed computationally and automatically without human intervention.
6 . The method of claim 1 , wherein each of the steps of processing the image data, determining the posterior surface, determining the anterior surface, generating the 3-D printable data set, and manufacturing the customized ocular contact lens is performed computationally and automatically without human intervention.
7 . The method of claim 1 , wherein sharp corners are computationally and automatically removed from the 3-D printable data set.
8 . The method of claim 1 , wherein processing the image data to generate a 3-D computational model of the outer surface of the cornea comprises: translating the image data into binarized images; using a Sobel edge detection function to delineate the cornea from the binarized images; and using a surface fit function to generate the 3-D computational model of the outer surface of the cornea.
9 . The method of claim 1 , wherein the selected optical power is selected from the range of −6D to +6D.
10 . The method of claim 1 , wherein the posterior surface is determined to have a shape complementary to a shape of the 3-D computational model.
11 . The method of claim 1 , wherein a best-fit spherical shape is generated based on the 3-D computational model, and the best-fit spherical shape is used to design the customized ocular contact lens; or wherein the anterior surface is determined using the lensmaker equation.
12 . The method of claim 1 , wherein the step of designing further comprises determining one or more edge surfaces connecting the anterior surface with the posterior surface.
13 . The method of claim 1 , wherein the additive manufacturing comprises projection micro-stereolithography (PuSL), micro-continuous liquid interface production (μCLIP), digital light processing (DLP), or any combination thereof.
14 . The method of claim 1 , wherein the additive manufacturing manufactures the customized ocular contact lens in a vertical orientation, such that each of a majority of printable layers of the customized ocular contact lens comprises a portion of both the posterior surface and the anterior surface.
15 . The method of claim 1 , wherein the entire method is completed within an hour or less.
16 . The method of claim 1 , wherein the steps of processing the image data, determining the posterior surface, determining the anterior surface, generating the 3-D printable data set, and manufacturing the customized ocular contact lens are completed within a total time of 30 minutes or less.
17 . The method of claim 1 , wherein the additive manufacturing has a voxel resolution of 6 μm or less.
18 . The method of claim 1 , wherein the customized ocular contact lens has a diameter selected from the range of 3 mm to 15 mm; wherein the customized ocular contact lens has a surface roughness of 2 nm of less; wherein the customized ocular contact lens has a thickness selected from the range of 300 μm to 700 μm; or wherein the customized ocular contact lens has a tolerance in thickness of less then 5%.
19 . The method of claim 1 , wherein the customized ocular contact lens has an absorbance of less than 1% at wavelengths selected from the range of 400 nm to 800 nm.
20 . The method of claim 1 , wherein the customized ocular contact lens has a refractive index between 1.4 and 1.6 for wavelengths selected from the range of 400 nm to 800 nm.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Patent Application No. 63/461,779, filed Apr. 25, 2023, which is hereby incorporated by reference in its entirety. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT This invention was made with government support under grant number EY034033 awarded by the National Institutes of Health. The government has certain rights in the invention. BACKGROUND OF INVENTION Additive manufacturing (AM), commonly known as three-dimensional (3D) printing, has undergone significant advancements. The ability to construct intricate and complex geometries with additive methods and directly translate the design model to the final product has not only enhanced design possibilities, but has also significantly reduced production costs and time, making AM an attractive option to be applied in a myriad of fields. Notably, AM revolutionized optical manufacturing processes by enabling the construction of complex geometries and design possibilities. Two-photon polymerization, as one of the highest spatial resolution 3D printing techniques which can achieve a sub-100 nm voxel resolution, has been demonstrated to fabricate micro- and nano-optics with complex lens design, however the application of two-photon polymerization was practically limited to produce microlenses due to its rather slow “point-by-point” fabrication nature. SUMMARY OF THE INVENTION Provided herein are systems and methods for additive manufacture of an ocular device in a fast and convenient manner, such as a ocular contact lens customized for a subject. In various aspects disclosed herein, methods disclosed herein provide for the imaging of the outer surface of a subject's cornea, designing a customized ocular contact lens based on the data from the imaging of the cornea, including determining anterior and posterior surfaces of the ocular contact lens, manufacturing the ocular contact lens using additive manufacturing, verifying the fit of the customized ocular contact lens on the subject's cornea, and verifying the optical power of the customized ocular contact lens. These features allow for the fast and convenient production of an ocular contact lens customized to a subject's cornea and manufactured to a specified optical power. Aspects disclosed herein include a method for additive manufacture of a customized ocular contact lens for a subject, the method comprising steps of: imaging and acquiring image data of an outer surface of a cornea of the subject using visible-light optical coherence tomography (vis-OCT); designing the customized ocular contact lens from the image data; manufacturing the customized ocular contact lens using additive manufacturing based on the a 3-D printable data set of the customized ocular contact lens; and verifying a shape of the manufactured customized ocular contacts lens by imaging the anterior surface and posterior surface of the manufactured customized ocular contact lens using vis-OCT. Aspects disclosed herein include a method for additive manufacture of a customized ocular contact lens for a subject, wherein designing the customized ocular contact lens from the image data comprises: processing the image data to generate a 3-D computational model of the outer surface of the cornea based on the acquired image data; determining a posterior surface of the customized ocular contact lens using the 3-D computational model; determining an anterior surface of the customized ocular contact lens to provide a selected optical power to the customized ocular contact lens; and generating a 3-D printable data set of the customized ocular contact lens comprising the determined posterior surface and the determined anterior surface. Aspects disclosed herein include the method of any of the previous aspects, wherein imaging the anterior surface and the posterior surface of the manufactured customized ocular contact lens comprises imaging the anterior surface and posterior surface of the manufactured customized ocular contact lens when the manufactured customized ocular contact lens is wet. Aspects disclosed herein include the method of any one of the previous aspects, wherein imaging the anterior surface and posterior surface of the manufactured customized ocular contact lens comprises imaging the anterior surface and posterior surface of the manufactured customized ocular contact lens when the manufactured customized ocular contact lens is suspended in a liquid. In some aspects, the liquid is water, oil, or diluted intralipid. Aspects disclosed herein include the method of any one of the previous aspects, wherein imaging the anterior surface and posterior surface of the manufactured customized ocular contact lens comprises imaging the anterior surface and posterior surface of the manufactured customized ocular contact lens when the manufactured customized ocular contact lens is positioned on and in contact with the cornea of the s