Patent Description:
Refractive treatment of an eye refers to techniques performed to change the refractive properties of the eye to reduce refractive error to improve vision. Refractive error occurs when parts of the eye do not bend light correctly, resulting in a blurred image. The main types of refractive errors are myopia (nearsightedness), hyperopia (farsightedness), presbyopia (loss of near vision with age), and astigmatism. Ocular implants are used in one type of refractive treatment. An ocular implant is implanted into the eye to change the refractive properties to improve vision.

From <CIT> a system and a method for 3D printing of a desired 3D object is known in which a pre-transformed material such as a powder material in a material bed is transformed by an energy beam. In particular, a layer of pre-transformed material is deposited using a layer dispensing mechanism and an energy beam is moved according to printing instructions for printing a 3D object. A metrological detector may be used in the control of the 3D printing, which may include an image detector such as a camera to monitor irregularities. The control system may use the metrology data to control parameters of the layer dispensing mechanism and to control parameters of the energy beam. <CIT> relates to 3D printing of a Printed Circuit Board or an electronic circuit. The system comprises a visual inspection module which is configured to take images of a trace line when printing the trace line, to process the images, to compare them to a planned design and to adjust the 3D printing process in dependence on the result of this comparison. <CIT> discloses a 3D printing process of a contact lens. <CIT> discloses a multi-material extrusion-based additive manufacturing method and apparatus.

The present disclosure provides a system for making an implant for an eye and a method for making an implant for an eye as defined in the independent claims.

The system for making an implant for an eye, inter alia, comprises a printer, a camera, and a computer. The printer prints material onto a target and has a printer head and printer controller. The printer head deposits the material onto the target, and the printer controller moves the printer head to deposit the material onto a specific location of the target. The camera generates an image to monitor the printing of the material. The computer stores a pattern for the implant, which is designed to provide refractive treatment for the eye; sends instructions to the printer controller to move the printer head to print the material onto the target according to the pattern; assesses the image from the camera according to the pattern; and adjusts the instructions in response to the image.

The method for making an implant for an eye, inter alia, includes storing a pattern for an implant designed to provide refractive treatment for the eye. Instructions are sent to a printer controller to move a printer head to print material onto a target according to the pattern. An image is generated to monitor the printing of the material. The image is assessed according to the pattern, and adjusting the instructions are adjusted in response to the image.

Embodiments of the present disclosure are described by way of example in greater detail with reference to the attached figures, in which:.

Referring now to the description and drawings, example embodiments of the disclosed apparatuses, systems, and methods are shown in detail. As apparent to a person of ordinary skill in the field, the disclosed embodiments are exemplary and not exhaustive of all possible embodiments.

<FIG> illustrates an example of a system <NUM> for making an implant <NUM> for an eye. System <NUM> includes a printer <NUM> that prints biological or biocompatible material onto a target, such as a stage <NUM>. A computer <NUM> sends instructions to printer <NUM> to print the material according to a pattern <NUM>. Pattern <NUM> is designed to yield implant <NUM> that provides refractive treatment to an eye when implanted into the eye. A camera <NUM> generates images to monitor the printing of the material. Computer <NUM> assesses the images according to pattern <NUM> and may adjust the instructions in response to the image. An ablation laser may shape the printed material, and a curing illuminator <NUM> may cure the printed material.

The system <NUM> comprises computer <NUM>, printer <NUM>, stage <NUM>, ablation laser <NUM>, camera <NUM>, and curing illuminator <NUM>. Computer <NUM> includes one or more processors <NUM> and one or more memories <NUM> that store pattern <NUM>. Printer <NUM> includes a printer head <NUM> and a printer controller <NUM>. The computer <NUM> controls the components of system <NUM> to make implant <NUM> according to pattern <NUM>. Stage <NUM> is a platform that operates as either a target for printed material or a supports the target for the printed material. Printer <NUM> prints material onto the target. Ablation laser <NUM> ablates the printed material to shape the printed material according to pattern <NUM>. Curing illuminator <NUM> illuminates the printed material with a light that promotes curing of the material. Camera <NUM> generates images to monitor the creation of implant <NUM>. To aid in description, this description refers a coordinate system used in printing. In this coordinate system, the direction in which the printed material is ejected defines the z-axis, and the xy-plane is the plane normal to the z-axis.

Implant <NUM> is an ocular implant, i.e., an artificial aid surgically implanted into an eye to provide refractive treatment for the eye. When implant <NUM> is implanted into an eye and the eye recovers from the implantation, implant <NUM> changes the refractive properties of the eye to improve vision. Examples of implant <NUM> include a corneal inlay, corneal onlay, intraocular lens, or corneal transplant. In the case of a corneal transplant, system <NUM> creates "donor" tissue that may include cell layers like epithelial, Bowman, stromal, and/or endothelial cells. Donor tissue may be created for a full thickness cornea transplant (i.e., a penetrating keratoplasty) or a back layer cornea transplant (i.e., an endothelial keratoplasty).

Implant <NUM> may have any suitable size or shape. For example, implant <NUM> may be circular or annular with a diameter in the range of <NUM> to <NUM> millimeters (mm), or in a sub-range such as <NUM> to <NUM>, <NUM> to <NUM>, or <NUM> to <NUM>. In certain embodiments, implant <NUM> may comprise material printed on a transparent biocompatible substrate. (Examples of such printed material are described below. ) In other embodiments, implant <NUM> may comprise the printed material, but not a substrate. An effective area of an implant <NUM> may be the area through which the eye sees, e.g., the area circumscribed by the pupil at its largest size.

Pattern <NUM> describes the external size and shape of implant <NUM> and may also describe internal structures of implant <NUM>. Internal structures may result from how printed material is deposited, cured, and/or ablated during creation of implant <NUM>. In certain embodiments, pattern <NUM> may define how material should be deposited, cured, and/or ablated at each layer that forms implant <NUM>. For example, pattern <NUM> may define how a first layer should be made by describing where material should be deposited, whether and how the material should be cured, and/or whether and how the material should be ablated. Pattern <NUM> may define how subsequent layers should be made using a similar type of description. Examples of implants <NUM>, internal structures, and patterns <NUM> are illustrated in <FIG>.

Printer <NUM> may be any suitable printer configured to deposit material onto a target according to digital instructions. For example, printer <NUM> may be a 3D (or additive manufacturing) printer that deposits successive layers of material to yield printed material configured in a specific shape and size. Printer <NUM> includes printer head <NUM> and printer controller <NUM>. Printer head <NUM> directs material onto the target and may be any suitable printer extruder that deposits material onto a surface. Printer controller <NUM> moves the printer head in the x, y, z directions to direct the material onto a specific location of the target, and may receive instructions from computer <NUM> to move the printer head <NUM> according to pattern <NUM>.

Printer <NUM> prints material that comprises any suitable transparent or semitransparent material that is biological and/or biocompatible. Examples of such material include cultivated collagen material, human or animal cell material, biocompatible plastic, hyaluronan, recombinant human collagen III (RHCIII), gelatin methacrylate, and silk. In certain cases, a material over which the epithelium can grow may be used. Such material may provide optimal nutrition of corneal cells and extra-cellular material, optical transparency over lifetime, and supportive surface properties for epithelium growth.

Printer <NUM> prints material onto a target, which may be stage <NUM> or an implant substrate supported by stage <NUM>. In certain embodiments, an implant substrate may be a mold that shapes the surface of material that is deposited on the mold. The mold may be removed prior to implantation of implant <NUM> into an eye. In other embodiments, an implant substrate may form a part of implant <NUM>, and is implanted into an eye with the rest of the implant <NUM>. In these embodiments, the implant substrate may comprise a transparent or semitransparent material that is biological and/or biocompatible, as described above.

Ablation laser <NUM> ablates printed material to shape the material according to pattern <NUM>. Ablation laser <NUM> may be any suitable laser device that generates and emits a laser beam that ablates the printed material. Ablation laser <NUM> may comprise a laser source (e.g., excimer or femto) that generates a laser beam, and scanning components (e.g., optics) that direct the focus of the laser beam to specific points of the target. In certain embodiments, laser <NUM> may incorporate additional laser sources that generate different laser beams, e.g., laser <NUM> may have sources that generate a beam that photodisrupts or crosslinks the printed material and a beam that ablates the printed material. Computer <NUM> may instruct ablation laser <NUM> to shape the material by describing where the material should be ablated.

Curing illuminator <NUM> direct a curing light towards the printed material to cure the material. The light may cure the material by promoting cross-linking of the material. Examples of curing light include ultraviolet light or light (such as LED light) between <NUM> to <NUM>. Computer <NUM> may instruct curing illuminator <NUM> to cure material by indicating when the material should be cured, the curing time, and/or the curing intensity.

Camera <NUM> generates images of the printed material to monitor the printing of the material. Camera <NUM> may comprise any suitable system that can generate an image of an object. An optical coherence tomography (OCT) system (such as a time domain or frequency domain OCT system) that generates OCT scans to generate the image is an example of camera <NUM>. Other examples include a Scheimpflug system (light section measurement) or a stereoscopic camera system.

Computer <NUM> sends instructions to the components of system <NUM> to tell the components how to operate to make implant <NUM> according to pattern <NUM>. For example, computer <NUM> send instructions to printer controller <NUM> to move printer head <NUM> to print the material according to pattern <NUM>. In certain embodiments, computer <NUM> can also send instructions to ablation laser <NUM> to ablate the printed material according to pattern <NUM>, and/or to curing illuminator <NUM> to direct the curing light according to pattern <NUM>.

In addition, computer <NUM> assesses images from camera <NUM> and can adjust the instructions in response to the image. Computer <NUM> may assess the image according to pattern <NUM> by comparing the image to pattern <NUM> to determine differences between the image and pattern <NUM>. Computer <NUM> may image process the image to identify features of the image that correspond to the same features of implant <NUM> defined by pattern <NUM>. The features may be, e.g., an external shape or size or an internal structure. The corresponding features are compared to detect any differences. If a difference is detected, the instructions may be adjusted to reduce the difference. For example, if the image shows material where pattern <NUM> indicates there should be no material, computer <NUM> may send instructions to ablation laser <NUM> to ablate the unwanted material. As another example, if the image shows no material where pattern <NUM> indicates there should be material, computer <NUM> may send instructions to printer <NUM> to deposit more material.

Computer <NUM> may perform the assessment and adjustment at any suitable time during the creation of implant <NUM>. For example, computer <NUM> may continually perform the assessment and adjustment, or may perform the assessment and adjustment at certain times, e.g., after forming a layer and before forming a new layer.

<FIG> illustrates an example of a method for making an implant <NUM> for an eye, which may be performed by system <NUM> of <FIG>. The method starts at step <NUM>, where computer <NUM> accesses pattern <NUM> for making ocular implant <NUM>. Computer <NUM> sends instructions to components of system <NUM> at step <NUM> to tell the components how to operate to make implant <NUM> according to pattern <NUM>. For example, computer <NUM> sends instructions to: printer <NUM> at step 102a to print material according to pattern <NUM>; curing illuminator <NUM> at step 102b to direct the curing light towards the printed material according to pattern <NUM>; and/or ablation laser <NUM> at step 102c to ablate the printed material according to pattern <NUM>.

Camera <NUM> generates images of the printed material, and computer <NUM> assesses the images at step <NUM>. Computer <NUM> may assess the image according to pattern <NUM> by comparing the image to pattern <NUM> to determine differences between a feature (e.g., an external shape or size or an internal structure) of the image and a corresponding feature defined by pattern <NUM>. Computer <NUM> determines if the printed material is satisfactory at step <NUM>. The printed material may be satisfactory if there are no differences or only negligible between the features. A negligible difference may be a difference that causes no noticeable difference in the resulting vision.

If the printed material is not satisfactory at step <NUM>, the method proceeds to step <NUM>, where computer <NUM> adjusts the instructions in response to the image. The instructions may be adjusted to reduce the difference between the imaged feature and the pattern feature. For example, instructions may be adjusted to remove unwanted material or deposit needed material. In the first case, the instructions may instruct ablation laser <NUM> to ablate unwanted material. In the second case, the instructions may instruct printer <NUM> to print needed material.

If the printed material is satisfactory at step <NUM>, the method proceeds to step <NUM>, where computer <NUM> determines if the implant forming process is finished. If the process is not finished, the method returns to step <NUM> to send more instructions. If the process is finished, the method ends.

<FIG> illustrate examples of implants <NUM> with different external shapes that may be made by system <NUM> of <FIG>. Implant 12a of <FIG> may be used for correction of hyperopia, and implant 12b of <FIG> may be used for correction of myopia. <FIG> illustrate a top view of implants 12a and 12b, respectively, and <FIG> illustrate a cross-section view of implants 12a and 12b, respectively, along line A-A.

<FIG> illustrate examples of implants 12c to 12e with different internal structures that may be made by system <NUM> of <FIG>. Implants 12c to 12e are made by depositing layers <NUM>, which may be defined by the patterns for implants 12c to 12e. Each figure shows formation of layers <NUM> in the effective area of implant <NUM>. In each figure: step (<NUM>) shows layer 50a deposited onto a target (which may be stage <NUM> or an implant substrate); step (<NUM>) shows layer 50b deposited onto layer 50a and/or the target; and step (<NUM>) shows layer 50c deposited onto layer 50b. As each layer <NUM> is deposited (and optionally cured and/or ablated), it forms an internal structure that can affect the refractive properties of implant <NUM>.

<FIG> illustrates an implant 12c with layers <NUM>, where each layer <NUM> has substantially the same thickness. Layer 50a has a uniform curvature, and subsequent layers 50b and 50c have similar uniform curvature. Steps (4a) and (4b) illustrate how implant 12c can be ablated in different ways to yield different types of refractive correction. Step (4a) illustrates layers <NUM> ablated to yield an external shape similar to that of implant 12a of <FIG> for correction of hyperopia. Step (4b) illustrates layers <NUM> ablated to yield an external shape similar to that of implant 12b of <FIG> for correction of myopia.

<FIG> illustrate implants 12d and 12e with layers <NUM>, where layer 50a does not have the same thickness over the effective area, so subsequent layers 50b and 50c do not have a curvature similar to that of layer 50a. In <FIG>, layer 50a is deposited in the central, but not peripheral, area of implant 12d. Subsequent layers 50b and 50c are deposited, which results in an external shape similar to that of implant 12a of <FIG> for correction of hyperopia. However, even though implant 12d and implant 12c of Step (4a) of <FIG> have similar external shapes, their internal structures are different.

In <FIG>, layer 50a is deposited in the peripheral, but not central, area of implant 12e. Subsequent layers 50b and 50c are deposited, which results in an external shape similar to that of implant 12b of <FIG> for correction of myopia. However, even though implant 12e and implant 12c of Step (4b) of <FIG> have similar external shapes, their internal structures are different.

A component (e.g., a computer) of the systems and apparatuses disclosed herein may include an interface, logic, and/or memory, any of which may include hardware and/or software. An interface can receive input to the component, provide output from the component, and/or process the input and/or output. Logic can perform the operations of the component, e.g., execute instructions to generate output from input. Logic may be a processor, such as one or more computers or one or more microprocessors. Logic may be computer-executable instructions encoded in memory that can be executed by a computer, such as a computer program or software. A memory can store information and may comprise one or more tangible, non-transitory, computer-readable, computer-executable storage media. Examples of memory include computer memory (e.g., Random Access Memory (RAM) or Read Only Memory (ROM)), mass storage media (e.g., a hard disk), removable storage media (e.g., a Compact Disk (CD) or a Digital Video Disk (DVD)), and network storage (e.g., a server or database).

Claim 1:
A system (<NUM>) for making an implant (<NUM>) for an eye, comprising:
a printer (<NUM>) configured to print material onto a target (<NUM>), the printer (<NUM>) comprising:
a printer head (<NUM>) configured to deposit the material onto the target (<NUM>); and
a printer controller (<NUM>) configured to move the printer head (<NUM>) to deposit the material onto a specific location of the target (<NUM>);
a camera (<NUM>) configured to generate an image to monitor the printing of the material;
an ablation laser (<NUM>) configured to shape the printed material;
a computer (<NUM>) configured to:
store a pattern (<NUM>) for the implant (<NUM>), the implant (<NUM>) designed to provide refractive treatment for the eye and the pattern (<NUM>) defining an external size and shape of the implant (<NUM>);
send instructions to the printer controller (<NUM>) to move the printer head (<NUM>) to print the material onto the target (<NUM>) according to the pattern (<NUM>);
send instructions to the ablation laser (<NUM>) to ablate the printed material according to the pattern (<NUM>);
assess the image from the camera (<NUM>) according to the pattern (<NUM>) by:
identifying an external size and shape of the printed material in the image; and
comparing the identified external shape and size with the external shape and size of the implant (<NUM>) defined by the pattern (<NUM>) to determine a difference between the identified external shape and size of the image and the external shape and size of the implant (<NUM>) defined by the pattern (<NUM>); and
adjust the instructions in response to the image to reduce a determined difference by instructing the printer (<NUM>) to print needed material or instructing the ablation laser (<NUM>) to ablate unwanted material.