CN112168425B - Method for preparing artificial cornea posterior plate - Google Patents
Method for preparing artificial cornea posterior plate Download PDFInfo
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- CN112168425B CN112168425B CN202011059310.2A CN202011059310A CN112168425B CN 112168425 B CN112168425 B CN 112168425B CN 202011059310 A CN202011059310 A CN 202011059310A CN 112168425 B CN112168425 B CN 112168425B
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- rear plate
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
- A61F2/142—Cornea, e.g. artificial corneae, keratoprostheses or corneal implants for repair of defective corneal tissue
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B23—MACHINE TOOLS; METAL-WORKING NOT OTHERWISE PROVIDED FOR
- B23P—METAL-WORKING NOT OTHERWISE PROVIDED FOR; COMBINED OPERATIONS; UNIVERSAL MACHINE TOOLS
- B23P15/00—Making specific metal objects by operations not covered by a single other subclass or a group in this subclass
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- C—CHEMISTRY; METALLURGY
- C21—METALLURGY OF IRON
- C21D—MODIFYING THE PHYSICAL STRUCTURE OF FERROUS METALS; GENERAL DEVICES FOR HEAT TREATMENT OF FERROUS OR NON-FERROUS METALS OR ALLOYS; MAKING METAL MALLEABLE, e.g. BY DECARBURISATION OR TEMPERING
- C21D9/00—Heat treatment, e.g. annealing, hardening, quenching or tempering, adapted for particular articles; Furnaces therefor
- C21D9/0075—Heat treatment, e.g. annealing, hardening, quenching or tempering, adapted for particular articles; Furnaces therefor for rods of limited length
-
- C—CHEMISTRY; METALLURGY
- C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
- C22F—CHANGING THE PHYSICAL STRUCTURE OF NON-FERROUS METALS AND NON-FERROUS ALLOYS
- C22F1/00—Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working
- C22F1/16—Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working of other metals or alloys based thereon
- C22F1/18—High-melting or refractory metals or alloys based thereon
- C22F1/183—High-melting or refractory metals or alloys based thereon of titanium or alloys based thereon
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
- A61F2240/002—Designing or making customized prostheses
Abstract
The invention specifically discloses a preparation method of a back plate of an artificial cornea, which is applied to the production process of a collar button type back plate of the artificial cornea and comprises the following steps: s1, preparing a processing blank, and inputting the processing blank into a numerical control lathe; taking a metal bar as a processing blank of the back plate; s2, processing the processing blank into a rear plate by using a numerical control lathe according to a set processing program; s3, deburring the rear plate; s4, cleaning the rear plate; s5, drying the rear plate; and S6, packaging and sterilizing the rear plate. The invention improves the precision of the collar button type artificial cornea back plate, realizes the batch and standardized production of the collar button type artificial cornea back plate, greatly improves the production efficiency and the qualification rate of finished products, and reduces the risk of pollution of the collar button type artificial cornea back plate in the preparation process.
Description
Technical Field
The invention relates to the technical field of biomedical engineering and artificial cornea production, in particular to a preparation method of an artificial cornea posterior plate.
Background
In 7 months in 2019, according to the media reports of multiple families such as people network and southern city newspaper: "China independently develops the first collar button type artificial cornea clinical test successfully". This means that the medical application of the domestic collar button type artificial cornea takes an important step, and the artificial cornea is primarily suitable for clinical application, but the optimization of the structure and the industrialized production of the artificial cornea still need to be researched and developed. As shown in fig. 1 and 4, the neckline keratoprosthesis includes a lens column 1, a back plate 3 as a mounting frame of the lens column 1, and a retainer ring 4 (reference numeral 2 in fig. 1 is a corneal implant) which is fastened to the outer side of one end of the lens column 1. The lens column is made of transparent material with excellent optical characteristics and stable physicochemical properties, and is used for replacing turbid cornea which obstructs an optical pathway of an eyeball after pathological changes, so that good optical resolution is required. The back plate is made of a hard material with good biocompatibility, the back plate is provided with a central through hole for mounting the lens column, and the back plate plays a role in supporting the carrier cornea, so that the back plate can be attached to the cornea only by a certain curvature. In addition, the common preparation method of the artificial cornea posterior plate also comprises 3D printing forming or mould casting integral forming, the preparation process is relatively complicated, the method is difficult to adapt to batch and standardized production, the preparation process is easy to be polluted, the product precision is low, and the rehabilitation difficulty is increased and the visual definition is reduced.
Disclosure of Invention
In view of the above, there is a need to provide a method for preparing a posterior plate of artificial cornea, which can improve the precision of the collar-clasping type posterior plate of artificial cornea, and can realize batch and standardized production of the collar-clasping type posterior plate of artificial cornea, thereby greatly improving the production efficiency and the qualification rate of finished products, and reducing the risk of contamination of the posterior plate of artificial cornea during the preparation process.
In order to realize the purpose, the invention adopts the following technical scheme:
a preparation method of a back plate of an artificial cornea is applied to the production process of a collar button type back plate of the artificial cornea and comprises the following steps:
s1, preparing a processing blank, and inputting the processing blank into a numerical control lathe; taking a metal bar as a processing blank of the back plate;
s2, processing the processing blank into a rear plate by using a numerical control lathe according to a set processing program;
s3, deburring the rear plate;
s4, cleaning the rear plate;
s5, drying the rear plate;
and S6, packaging and sterilizing the rear plate.
Further, between S2 and S3, the method further comprises:
s231: cleaning the rear plate;
s232: and detecting the rear plate to remove unqualified products.
Further, a step S415 is further provided between S4 and S5: and carrying out sand blasting treatment and cleaning after the sand blasting treatment on the back plate.
Further, a step S425 is further provided between S415 and S5: and carrying out oxidation treatment and cleaning after the oxidation treatment on the rear plate.
Furthermore, the rear plate is arc-shaped and provided with a central through hole, and a plurality of distributed through holes are annularly formed in the rear plate along the central through hole; at S2, the machining program forms a machining process by a numerically controlled lathe, the machining process including the steps of:
s222, roughly turning the processed blank to obtain an inner arc surface of the back plate;
s223, roughly turning the workpiece obtained in the step S222 so as to form a plurality of end surface holes corresponding to the distribution through holes;
s224, roughly turning the workpiece obtained in the step S223 into an outer arc surface of the back plate;
s225, performing repeated finish turning on the inner arc surface of the workpiece obtained in the S224;
s226, performing repeated finish turning on the outer arc surface on the workpiece obtained in the S225;
s227, performing repeated finish turning on the end surface hole on the workpiece obtained in the S226 to machine the distribution through hole;
s228, drilling the workpiece obtained in the step S227 so as to machine a rough machining center hole corresponding to the center through hole;
s229, boring the rough-machined center hole on the workpiece obtained in S228, thereby machining a finish-machined center hole corresponding to the center through hole;
s2210, chamfering the finish-machined center hole on the workpiece obtained in S229 with an inner hole grooving tool to machine the center through hole;
s2211, the workpiece obtained in S2210 is cut, thereby obtaining the rear plate.
Further, before S222, a step S221 is further provided:
and S221, carrying out zero point positioning by the numerical control lathe.
Further, in S4, the rear plate is cleaned using an ultrasonic cleaner.
Further, in S6, the rear panel and its package are sterilized by ethylene oxide and an over sterilization method.
Further, in S1, the metal bar as the rear plate processing blank is a titanium alloy or a titanium metal; the metal bar is machined by a numerical control lathe after secondary annealing treatment and secondary subzero treatment.
Further, the annealing temperature of the first annealing treatment is greater than or equal to 255 ℃ and less than or equal to 265 ℃, and the annealing temperature of the second annealing treatment is greater than or equal to 700 ℃ and less than or equal to 800 ℃; the first subzero treatment temperature is greater than or equal to-180 deg.C and less than or equal to-100 deg.C, and the second subzero treatment temperature is greater than or equal to-230 deg.C and less than or equal to-200 deg.C.
The invention has the beneficial effects that:
according to the invention, the automatic feed and tool change machining process is realized on the machined blank through the numerical control lathe according to the machining program, the machined workpiece meets the clean requirement of the ophthalmic surgery through the deburring and cleaning processes, and the cleaned artificial cornea back plate meets the E0-level medical sanitation requirement through the drying treatment, the packaging treatment and the sterilization treatment, so that the batch and standardized production of the collar button type artificial cornea back plate is realized, the production efficiency and the finished product qualification rate are greatly improved, and the risk of pollution of the collar button type artificial cornea back plate in the preparation process is reduced. The invention can improve the precision of the collar button type artificial cornea back plate, the back plate with high precision conforms to the eye structure of a human body, and the comfort of a patient after implantation can be improved; the numerical control lathe automatically executes the machining process, so that the process that the clamp needs to be installed again on the workpiece is omitted, and the production efficiency is improved; the mode of forming curvature integrally through the center-walking processing of the numerical control lathe enables the processed back plate to have no internal stress and the back plate and the lens column of the collar button type artificial cornea to be tightly matched. In addition, the invention also improves the biocompatibility of the back plate.
Drawings
FIG. 1 is an exploded view of a neckline keratoprosthesis according to the present invention;
FIG. 2 is a flow chart of the operation of a method for preparing a posterior plate of an artificial cornea according to the present invention;
FIG. 3 is a feed path and a process diagram of a machining process according to the present invention;
FIG. 4 is a perspective view of a neckline keratoprosthesis according to the present invention with respect to an eyeball;
description of reference numerals:
a lens barrel 1; a corneal implant 2; a rear plate 3; a central through hole 31; a collar 4; the blank 300 is processed.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention clearer, the technical solutions of the present invention will be further clearly and completely described below with reference to the embodiments of the present invention. It should be noted that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
It is to be understood that the terms "upper", "lower", "front", "rear", "left", "right", and the like, are used in the orientations and positional relationships indicated in the drawings for convenience in describing the present invention and simplifying the description, and do not indicate or imply that the referenced devices or elements must have a particular orientation, be constructed and operated in a particular orientation, and thus are not to be construed as limiting the present invention.
Examples
As shown in fig. 1-2:
a preparation method of a keratoprosthesis backplate is applied to the production process of a collar button type keratoprosthesis backplate 3, and comprises the following steps:
s1, preparing a processing blank, and inputting the processing blank into a numerical control lathe; a metal bar is used as a processing blank 300 of the back plate 3; specifically, the metal bar enters a numerical control lathe through an automatic feeding device;
s2, processing the processing blank 300 into the rear plate 3 by using a numerically controlled lathe according to the set processing program;
s3, deburring the rear plate 3; specifically, the rear plate 3 is subjected to deburring treatment by rotating the abrasive polisher, and then the rear plate 3 is screened out by a mesh screen;
s4, cleaning the rear plate 3;
s5, drying the rear plate 3; specifically, drying treatment is carried out by using a centrifugal drying mode and a plasma fan drying mode;
s6, the rear panel 3 is packaged and sterilized.
Further, between S2 and S3, the method further comprises:
s231: cleaning the rear plate;
s232: detecting the rear plate to remove unqualified products; specifically, after links including dimension measurement, appearance inspection and the like are completed, the rear plate is placed in the temporary storage cabinet for natural drying, and then deburring is performed.
Further, a step S415 is further provided between S4 and S5: carrying out sand blasting treatment and cleaning after the sand blasting treatment on the back plate 3; specifically, an ultrasonic cleaning machine is used for adding water for cleaning; the natural color of pure titanium is silver with metal reflection, if the surface of the material is not processed, strong reflection can be generated under the irradiation of an operating lamp during implantation, so that great discomfort is caused to an operator, in addition, after the silver titanium back plate is implanted into an eye, the appearance of a patient is greatly different from that of a brown eyeball of a normal Chinese person, the surface of the titanium back plate is subjected to sand blasting, the problem of strong reflection under the irradiation of the operating lamp is solved, and the biocompatibility of the back plate 3 can be improved through the sand blasting.
Further, a step S425 is further provided between S415 and S5: carrying out oxidation treatment and cleaning after the oxidation treatment on the rear plate 3; specifically, an ultrasonic cleaning machine is used for adding water for cleaning; after oxidation treatment, coloring contrast is needed, the surface of the back plate is oxidized into a color similar to the color of the Chinese iris, the difference between the postoperative appearance of a patient and the normal eyes can be reduced, and the social confidence of the postoperative adaptation of the patient is increased.
Further, as shown in fig. 1-3, the rear plate 3 is arc-dish-shaped and is provided with a central through hole 31, and the rear plate 3 is annularly provided with a plurality of distribution through holes along the central through hole 31; in S2, the machining program forms a machining process by a numerically controlled lathe, the machining process including the steps of:
s222, roughly turning the processing blank 300 to obtain an inner arc surface of the rear plate 3;
s223, roughly turning the workpiece obtained in the step S222 so as to form a plurality of end surface holes corresponding to the distribution through holes;
s224, roughly turning the workpiece obtained in the step S223 into an outer arc surface of the back plate 3;
s225, performing repeated finish turning on the inner arc surface of the workpiece obtained in the S224;
s226, performing repeated finish turning on the outer arc surface on the workpiece obtained in the S225;
s227, performing repeated finish turning on the end surface hole on the workpiece obtained in the S226 to machine the distribution through hole;
s228, drilling the workpiece obtained in S227, thereby machining a rough machining center hole corresponding to the center through hole 31;
s229, boring the rough-machined center hole on the workpiece obtained in S228, thereby machining a finish-machined center hole corresponding to the center through-hole 31;
s2210 of chamfering the finish-machined center hole on the workpiece obtained in S229 with an inner-hole grooving tool to machine the center through-hole 31;
s2211, the workpiece obtained in S2210 is cut, thereby obtaining the rear plate 3.
Further, as shown in fig. 3, before S222, a step S221 is further provided:
s221, positioning a machining zero point of the numerical control lathe, and improving machining precision;
the process sequence of steps S221 to S2211 ensures the machining accuracy of the back plate 3 and improves the production efficiency of the back plate 3, and the fine structure of the machined back plate 3 meets the requirements of ophthalmological biocompatibility and postoperative visual definition.
Further, in S4, the rear plate 3 is cleaned using an ultrasonic cleaner; impurities or debris generated during the manufacturing process can seriously affect eye health and increase the risk of surgical infection, requiring high cleanliness of the back plate 3.
Further, in S6, the rear panel 3 and its package are sterilized by ethylene oxide and an over-sterilization method; specifically, ethylene oxide sterilizes the rear plate 3 through the packed dialysis paper.
Further, as shown in fig. 1 to 3, in S1, the metal bar material as the rear plate 3 processing blank 300 is a titanium alloy or a titanium metal; the metal bar is machined by a numerical control lathe after secondary annealing treatment and secondary subzero treatment.
Further, the annealing temperature of the first annealing treatment is larger than or equal to 255 ℃ and smaller than or equal to 265 ℃, and the annealing temperature of the second annealing treatment is larger than or equal to 700 ℃ and smaller than or equal to 800 ℃; the first sub-zero treatment temperature is greater than or equal to-180 ℃ and less than or equal to-100 ℃, and the second sub-zero treatment temperature is greater than or equal to-230 ℃ and less than or equal to-200 ℃; the titanium metal back plate after the temperature range treatment meets the requirements of high precision, high biocompatibility and strong assembly adaptability.
The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the present invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.
Claims (7)
1. A preparation method of a back plate of an artificial cornea is applied to the production process of a collar button type back plate of the artificial cornea and is characterized by comprising the following steps:
s1, preparing a processing blank, and inputting the processing blank into a numerical control lathe; taking a metal bar as a processing blank of the back plate;
s2, processing the processing blank into a rear plate by using a numerical control lathe according to a set processing program;
s3, deburring the machined and molded rear plate;
s4, cleaning the rear plate;
s5, drying the rear plate;
s6, packaging and sterilizing the rear plate;
in S1, the metal bar as the rear plate processing blank is a titanium alloy or a titanium metal; the metal bar is machined by a numerical control lathe after secondary annealing treatment and secondary subzero treatment; the annealing temperature of the first annealing treatment is more than or equal to 255 ℃ and less than or equal to 265 ℃, and the annealing temperature of the second annealing treatment is more than or equal to 700 ℃ and less than or equal to 800 ℃; the cold treatment temperature of the first cryogenic treatment is greater than or equal to-180 ℃ and less than or equal to-100 ℃, and the cold treatment temperature of the second cryogenic treatment is greater than or equal to-230 ℃ and less than or equal to-200 ℃;
the rear plate is arc-shaped and provided with a central through hole, and a plurality of distribution through holes are annularly arranged along the central through hole; in S2, the machining program forms a machining process by a numerically controlled lathe, the machining process including the steps of:
s222, roughly turning the processed blank to obtain an inner arc surface of the back plate;
s223, roughly turning the workpiece obtained in the step S222 so as to form a plurality of end surface holes corresponding to the distribution through holes;
s224, roughly turning the workpiece obtained in the step S223 to form an outer arc surface of the back plate;
s225, performing repeated finish turning on the inner arc surface of the workpiece obtained in the S224;
s226, performing repeated finish turning on the outer arc surface on the workpiece obtained in the S225;
s227, performing repeated finish turning on the end surface hole on the workpiece obtained in the S226 to machine the distribution through hole;
s228, drilling the workpiece obtained in the step S227 so as to machine a rough machining center hole corresponding to the center through hole;
s229, boring the rough-machined center hole on the workpiece obtained in S228, thereby machining a finish-machined center hole corresponding to the center through hole;
s2210, chamfering the finish-machined central hole on the workpiece obtained in the S229 by an inner hole groove cutter, thereby machining the central through hole;
s2211, the workpiece obtained in S2210 is cut, thereby obtaining the rear plate.
2. The method of claim 1, further comprising between S2 and S3:
s231: cleaning the rear plate;
s232: and detecting the rear plate to remove unqualified products.
3. The method for preparing a keratoprosthesis posterior plate as claimed in claim 1, further comprising a step S415 between S4 and S5: and carrying out sand blasting treatment and cleaning after the sand blasting treatment on the back plate.
4. The method for preparing a keratoprosthesis backplate according to claim 3, wherein step S425 is further provided between S415 and S5: and carrying out oxidation treatment and cleaning after the oxidation treatment on the rear plate.
5. The method for preparing a keratoprosthesis posterior plate according to claim 1, further comprising step S221 before S222:
and S221, carrying out zero point positioning by the numerical control lathe.
6. The method for preparing a keratoprosthesis posterior plate according to claim 1, wherein in S4, the posterior plate is cleaned using an ultrasonic cleaning machine.
7. The method of claim 1, wherein the step of sterilizing the artificial corneal posterior plate and its packaging is performed by using ethylene oxide and an over-sterilization method in step S6.
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| CN202010286649X | 2020-04-13 | ||
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| CN112168425B true CN112168425B (en) | 2022-05-06 |
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Family Cites Families (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4772283A (en) * | 1986-05-16 | 1988-09-20 | White Thomas C | Corneal implant |
| US8506626B2 (en) * | 2007-05-24 | 2013-08-13 | The Board Of Trustees Of The University Of Illinois | Transcorneal vision assistance device |
| CN201782846U (en) * | 2010-07-23 | 2011-04-06 | 广东省视觉眼科学研究所 | Artificial cornea |
| CN103722182A (en) * | 2013-12-12 | 2014-04-16 | 郑丽萍 | Method for turning germanium lens |
| CN104645415A (en) * | 2014-11-28 | 2015-05-27 | 南昌大学第一附属医院 | Method for preparing decellularized lamellar cornea matrix sheet |
| CN204379849U (en) * | 2014-12-02 | 2015-06-10 | 浙江大学 | The collapsible artificial cornea of the front and rear surfaces difference modification that a kind of Nano ultrathin biomembrane is modified |
| US10893804B2 (en) * | 2015-10-05 | 2021-01-19 | Massachusetts Eye & Ear Infirmary | Measurement of intraocular pressure |
| CN105688282A (en) * | 2016-03-11 | 2016-06-22 | 广州宏畅生物科技有限公司 | Novel biological artificial cornea capable of realizing cellularization through in-vivo induction as well as realizing quick transparency |
| US10939993B2 (en) * | 2016-04-08 | 2021-03-09 | Massachusetts Eye And Ear Infirmary | Keratoprosthesis apparatuses, systems, and methods |
| WO2018107482A1 (en) * | 2016-12-16 | 2018-06-21 | 厦门大开生物科技有限公司 | Preparation method for decelluralized swine cornea, decellularized lamellar cornea thereof, and use method |
| CN109199637B (en) * | 2018-03-19 | 2021-05-04 | 广东佳悦美视生物科技有限公司 | Artificial cornea |
| CN208725957U (en) * | 2018-03-19 | 2019-04-12 | 翟嘉洁 | Artificial cornea back plate |
| CN110123520B (en) * | 2019-05-21 | 2024-03-26 | 广东普洛宇飞生物科技有限公司 | Amniotic membrane contact lens, preparation method and application |
| CN110420352A (en) * | 2019-07-01 | 2019-11-08 | 薛安全 | A kind of bion ocular tissue repair materials and preparation method thereof |
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