CN111419471A - Artificial cornea - Google Patents
Artificial cornea Download PDFInfo
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- CN111419471A CN111419471A CN202010148167.8A CN202010148167A CN111419471A CN 111419471 A CN111419471 A CN 111419471A CN 202010148167 A CN202010148167 A CN 202010148167A CN 111419471 A CN111419471 A CN 111419471A
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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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Abstract
The invention relates to an artificial cornea, in particular to an artificial cornea which is not easy to fall off, prevents aqueous humor from leaking and is beautiful and natural, and provides an artificial cornea comprising a central optical part and umbrella-shaped wings. The central optical part is a circular light-transmitting part, and the side surface of the central optical part is a rough surface; the edge of the central optical part comprises at least two fixing feet which are used for being inserted into corneal stroma of the implantation bed to realize the functions of fixing the central optical part and preventing the central optical part from being separated; the center of the umbrella-shaped wing is a round hole and is arranged opposite to the circular light-transmitting part, and the diameter of the round hole at the center of the umbrella-shaped wing is smaller than or equal to that of the circular light-transmitting part; the outer side of the central circular hole of the umbrella-shaped wing is provided with an annular leakage-proof area; the outer side of the umbrella-shaped wing annular leakage-proof area comprises at least two side wings, and the side wings comprise biological integration areas for biological integration with the conjunctiva.
Description
Technical Field
The invention relates to an artificial cornea, in particular to an artificial cornea which is difficult to fall off, prevents aqueous humor from leaking and is beautiful and natural.
Background
The corneal transplantation technology is mature, but donor corneas are far from meeting the requirements of a large number of patients with corneal diseases. In addition, patients may have rejection of the donor cornea, inducing other eye diseases. Thus, the artificial cornea provides a new choice for the treatment of patients.
The teaching hospital of the harvard medical college and the ophthalmology department of the massachusetts general hospital are commonly in the web page http:// www.djo.harvard.edu/site. php? A Boston-type Keratoprosthesis (BKPro) is a bowstring-designed corneal prosthesis, published in paper "the Boston Keratoprosthesis: A New Threadless Design" by url ═ physicans/oa/1055. It consists of three components: the front plate with the optical lens column, the back plate and the titanium locking C-shaped ring. The posterior plate typically has a hole with a diameter of 1.17mm (millimeters) to allow aqueous humor to enter the cornea above the posterior plate for nutrient metabolism. A paper, review on the melting of the cornea after Boston type I artificial cornea, DOI:10.3969/j.issn.2095-5227.2018.12.022, states that the melting of the cornea is one of the serious complications threatening the safety of Boston type I artificial cornea. Two of the reasons why implanted boston type I keratoprostheses are susceptible to corneal ablation are: (1) the split type design of front bezel and back plate causes the inevitable gap that produces between front bezel and the back plate. The gap not only ensures that the front plate and the back plate continuously rub to induce MMP expression when the eyeball moves, but also is easy to accumulate microorganisms to cause various eye diseases; (2) the back plate has no other path for the passage of nutrients except for the pre-set holes. Once the holes in the posterior plate are blocked by the proliferating RPM, the nutrient metabolism of the cornea above the posterior plate is affected and corneal thawing occurs. Another keratoprosthesis (chinese patent application No. 201810863340.5), similar to the boston-type keratoprosthesis, suffers from the same drawbacks.
Book "Keratoprostheses and Artificial Corneas", ISBN: 9783642551789, AlphaCor: the references, Techniques and Outcomes, describes an AlphaCor keratoprosthesis, 7mm in diameter, comprising a central optic portion and a skirt portion, integrally formed from poly (2-hydroxyethyl methacrylate, PHEMA) having different water contents. Journal "ophthalmology research" 2010, 6 th volume, 28 th volume, paper "AlphaCor artificial cornea transplantation for treating rabbit corneal alkali burn" describes that postoperative complications of the AlphaCor artificial cornea mainly include: (1) the implantation of the AlphaCor keratoprosthesis requires two operations, which is inconvenient for patients; (2) the artificial cornea skirt with the width less than 1.5mm is clamped and fixed by the front and back lamellar corneas of the receptor to form a centripetal tension, so that the artificial cornea is difficult to resist the external pushing force of the intraocular pressure on the artificial cornea, and the artificial cornea is easy to separate; (3) PHEMA material may affect the transparency of the central optic due to material deposition and tendency to self-calcify; (4) after the second stage of operation, the plane of the central optical part is lower than the plane of the peripheral corneal anterior lamina, so that the exposed central optical area is more easily subjected to secretion adhesion and anterior lamina implantation edge fibroplasia, and the vision of a patient is affected; (5) the AlphaCor keratoprosthesis has an overall diameter of 7.00mm (millimeter), is located in the center of the implant bed, is only 1/2 strong in the area of the whole receptor cornea, and has an opaque outer skirt portion which is, by contrast, significantly different from a normal cornea and is not beautiful and natural. (6) Glaucoma is caused. Since the AlphaCor artificial cornea implantation needs to use the receptor cornea which is mostly contracted and flattened due to pathological changes, when the artificial cornea is implanted between the front and back laminae, the anterior chamber angle is narrowed due to the influence of the receptor cornea-artificial cornea composite layer moving backwards, and the occurrence rate of glaucoma is increased. Similar to the AlphaCor keratoprosthesis disclosed in Chinese patent application No. 201810315689.5, the same deficiencies exist.
"Artificial cornea and use thereof" patent application (hereinafter referred to as "391 patent") and Yougu webpage of Chinese application No. 201680033439.1
https:// v.youku.com/v _ show/id _ XMzY3ODIyOTgzNg ═ html? Seo _ operation. liuxiao. liux _00003303_3000_ Qzu6 _ 6ve _19042900 discloses a keratoprosthesis structure and procedure of CorNeatVision. The CorNeat keratoprosthesis includes a central optic and a peripheral coaptation rim (integration rim) and is peripherally attached to the central optic with an integrated skirt (non-degradable porous) made of a non-degradable porous material, interposed between the conjunctiva and sclera, in an attempt to ensure stability of the keratoprosthesis after implantation in the corneal tissue of a human body. The CorNeat artificial cornea has the following defects: (1) the post-castellation (posteror-turret) design employed to prevent the artificial cornea from herniating is a contact-type relationship rather than a tight bond between the artificial cornea and the recipient cornea, the artificial cornea is susceptible to rotational displacement under the influence of eyelid movement, and the recipient corneal back surface contacted by the post-castellation is susceptible to post-castellation resulting in edema and thawing of the graft. (2) The nanometer pores of the integrated skirt edge are very small, the time for biological integration of the pores which can be seen under an optical microscope or even an electron microscope is very long, and the integrated tissues are not strong enough and can not effectively fix the CorNeat artificial cornea; (3) the interface between the central optic and the recipient cornea is smooth and prone to movement due to eye movement, the recipient cornea is subject to abrasion, and the gap between the two is thus enlarged, followed by aqueous humor leakage. (4) Although the central optic edge is marked for future intraoperative incision, since the integrated skirt is dome-shaped, if other intraocular surgeries are performed after the keratoprosthesis implantation, the incision needs to be incised through the integrated skirt, and the adhesion between the cornea and the sclera which are not compact is inevitably damaged.
At present, the artificial corneas do not meet the ideal requirements, and have the complications of easy prolapse, aqueous humor leakage, undersized optical part, unattractive appearance and the like.
Therefore, there is a need for an artificial cornea that is not easily detached, prevents leakage of aqueous humor, and is beautiful and natural.
Disclosure of Invention
In view of the above, the present invention provides an artificial cornea that is not easily detached, prevents aqueous humor from leaking, and is beautiful and natural. In order to achieve the purpose, the invention adopts the following technical scheme:
an artificial cornea, a central optic portion and an umbrella-shaped wing; the central optical part is a circular light-transmitting part, and the side surface of the central optical part is a rough surface; the edge of the central optical part comprises at least two fixing feet, and the fixing feet are used for being inserted into corneal stroma of the implantation bed to realize the functions of fixing the central optical part and preventing the central optical part from being separated; the center of the umbrella-shaped wing is a round hole and is used for being arranged opposite to the circular light-transmitting part, and the diameter of the round hole at the center of the umbrella-shaped wing is smaller than or equal to that of the circular light-transmitting part; the outer side of the central circular hole of the umbrella-shaped wing is provided with an annular leakage-proof area; the outer side of the umbrella-shaped wing annular leakage-proof area comprises at least two side wings, and the side wings comprise biological integration areas for biological integration with the conjunctiva.
Preferably, the fixing foot of the central optical part of the artificial cornea is trapezoidal, and the arc length of the connecting part of the fixing foot and the circular light-transmitting part is shorter than that of the side far away from the circular light-transmitting part.
Preferably, the fixation legs of the central optic of the keratoprosthesis have through holes.
Preferably, the outer circumferential edge of the annular leakage prevention region of the artificial cornea exceeds the corneal edge of the recipient, specifically, by 0.5 to 1.0 millimeters (mm), and the leakage prevention region is dense and non-porous.
Preferably, the bio-integral regions of the wings of the keratoprosthesis have micropores with a diameter greater than 20 micrometers (μm).
Preferably, the space between two adjacent wings of the artificial cornea is an operation reserved area, and the edge of one side of the operation reserved area close to the corneal limbus does not exceed the outer circle edge of the annular leakage-proof area.
Preferably, the circular hole at the center of the umbrella-shaped wing of the keratoprosthesis has a diameter of 8.0 to 8.5 millimeters (mm).
Preferably, the number of the fixing feet of the central optical part of the artificial cornea is three, and the fixing feet are uniformly distributed on the circumference of the same circle center as the circular light-transmitting part; the number of the side wings on the outer side of the annular leakage-proof area is four, and the four side wings are uniformly distributed on the circumference of the same circle center as the central circular hole of the umbrella-shaped wing.
Preferably, the length from the center of the circular light-transmitting part of the artificial cornea to the outer edge of the fixing foot is not more than 5.5 millimeters (mm).
Preferably, the umbrella-shaped wing of the artificial cornea can be folded and placed on the front surface of the central optical part, and the umbrella-shaped wing is restored to a spherical shape after the fixing legs of the central optical part are inserted into the implantation matrix at the time of surgery.
Drawings
FIG. 1a is a schematic representation of the components of a prior art Boston type I keratoprosthesis;
FIG. 1b is a schematic view of the Boston type I keratoprosthesis of FIG. 1a positioned on a recipient cornea;
FIG. 2 is a schematic representation of a prior art AlphaCor keratoprosthesis;
FIG. 3 is a schematic representation of a prior art CorNeat keratoprosthesis;
FIG. 4 is a schematic view of the components of a keratoprosthesis according to an embodiment of the present invention;
FIG. 5 is a schematic view of the central optic portion of a component of a keratoprosthesis according to an embodiment of the present invention;
figure 6 is a schematic view of an umbrella-shaped wing as a component of a keratoprosthesis according to an embodiment of the present invention.
Description of the main elements
| Name of the technology | Marking | Name of the technology | Marking |
| Boston type I |
10 | Peripheral |
302 |
| |
101 | |
3021 |
| Front plate cambered |
1011 | |
40 |
| |
1012 | Central optic | 401 |
| |
1013 | Circular |
4011 |
| |
102 | |
4012 |
| Rear plate through |
1021 | Circular light-transmitting |
4013 |
| Center hole of back plate | 1022 | Through hole of fixing pin | 4014 |
| C- |
103 | Umbrella- |
402 |
| Alphacor |
20 | Central circular hole of umbrella- |
4021 |
| Central optic | 201 | Annular leakage- |
4022 |
| Skirt |
202 | Umbrella- |
4023 |
| Corneat |
30 | Biological integration zone microwell | 4024 |
| Central |
301 | |
4025 |
| Groove | 3011 | Cornea | 500 |
| Hollow |
3012 | Conjunctiva (conjunctiva) | 600 |
Detailed Description
In order to make the objects, principles, technical solutions and advantages of the present invention more apparent, the present invention will be described in further detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are for purposes of illustration and are not intended to limit the invention, as described in this summary of the invention.
It should be particularly noted that, according to the connection or position relationship that can be determined according to the text or technical content of the specification, a part of the omitted or not-shown position change diagram is omitted for the simplicity of drawing, the omitted or not-shown position change diagram is not explicitly described in the specification, and cannot be considered to be omitted, and in the interest of brevity of description, the detailed description is not repeated one by one, and the description is unified herein.
Referring to fig. 1a and 1b, fig. 1a is a schematic diagram of the components of a prior art boston I artificial cornea 10, and fig. 1b is a schematic diagram of the boston I artificial cornea 10 after it is placed on a recipient cornea 500. As shown, the Boston-type keratoprosthesis 10 is a collar-clasped design keratoprosthesis. It consists of three components: a front plate 101 with an optical column 1012, a back plate 102 and a titanium locking C-ring 103. The front arc 1011 of the front plate 101 is integral with the optic cylinder 1012, and the end of the optic cylinder 1012 remote from the front arc 1011 contains an annular recess 1013. The posterior plate 102 includes a posterior plate central aperture 1022 and a posterior plate through aperture 1021 having a diameter of 1.17(mm), and aqueous humor passes through the posterior plate through aperture 1021 and into the cornea 500 above the posterior plate 102 for nutrient metabolism. During operation, the defective cornea 500 tissue is cut to form an implantation opening, the optical lens column 1012 of the front plate 101 passes through the implantation opening and then passes through the central hole 1022 of the back plate, so that the cornea 500 is clamped between the front plate arc surface 1011 and the back plate 102 of the front plate 101, the C-shaped ring 103 is buckled at the position of the annular groove 1013 of the optical lens column 1012, the Boston artificial cornea 10 is fixed on a receptor, and finally, the cornea 500 tissue and the Boston artificial cornea 10 are sutured.
However, in the paper "review of corneal ablation after type I keratoprosthesis of Boston (DOI:
10.3969/j.issn.2095-5227.2018.12.022), it was demonstrated that corneal ablation is one of the serious complications threatening the safety of boston type I keratoprostheses. Two of the reasons why the implanted bowden type I keratoprosthesis 10 is susceptible to ablation of the cornea 500 are: (1) the design of the front plate 101 and the rear plate 102 being separated from each other inevitably results in a gap between the front plate 101 and the rear plate 102. The gap not only ensures that the front plate 101 and the back plate 102 continuously rub to induce Matrix Metalloproteinase (MMP) expression during eyeball movement, but also is easy to accumulate microorganisms to cause various eye diseases; (2) the rear plate 102 has no other path for the passage of the nutrient substances except for the predetermined rear plate through holes 1021. Once the posterior plate through hole 1021 is blocked by the proliferating RPM, the nutrient metabolism of the cornea above the posterior plate will be affected and corneal ablation will occur. For example, corneal ablation can cause serious consequences such as endophthalmitis, aqueous humor leakage, low intraocular pressure, choroidal and/or retinal detachment, choroidal hemorrhage, keratoprosthesis prolapse, and the like. MMPs play an important role in the degradation of extracellular matrices such as collagen and mucopolysaccharides, and pathological corneal thawing occurs if excess MMPs are produced during normal corneal healing. In addition, the corneal stroma grows backward across the posterior elastic layer, and the metaplastic lens epithelium is involved, in which the proliferation of fibrovascular tissue on the posterior surface of the artificial cornea occurs as an artificial corneal posterior membrane (RPM), and when RPM blocks the posterior plate through hole 1021 of the boston-type artificial cornea posterior plate 102, there is no other path for nutrients such as aqueous humor to pass through the posterior plate 102, resulting in nutrient metabolism of the cornea above the posterior plate 102.
Referring to fig. 2, fig. 2 is a schematic view of a prior art AlphaCor keratoprosthesis 20. The AlphaCor keratoprosthesis 20 has a diameter of 7.00mm and includes a central optic 201 and a skirt 202, which are integrally formed of poly (2-hydroxyethyl methacrylate, PHEMA) having different water contents. The central optic 201 of the AlphaCor keratoprosthesis 20 is transparent PHEMA, providing the patient with the desired refraction. Skirt 202 of AlphaCor keratoprosthesis 20 is an opaque, high water content PHEMA sponge with a porous structure suitable for cell growth and collagen deposition for bio-integration. The interpenetration of the Polymer between the central optic 201 and the skirt 202 forms an Interpenetrating Polymer Network (IPN) that is capable of withstanding high compressive and tensile forces.
The surgical procedure for an AlphaCor keratoprosthesis is divided into two stages, separated by at least 3 months: first stage correct positioning of the AlphaCor keratoprosthesis 20 in the corneal layer, closing the wound with absorbable nylon sutures; the second stage resects the unwanted corneal tissue above the central optic 201 of the AlphaCor keratoprosthesis 20, exposing the central optic of the implanted AlphaCor keratoprosthesis 20 while the skirt 202 remains integrated in the cornea 500. However, the nylon thread used for suturing in the operation dissolves after several years, and the fixing force formed by the skirt 202 integrated in the cornea 500 alone is insufficient to hold the AlphaCor keratoprosthesis 20 in the cornea, and the keratoprosthesis is easily detached. After surgery, PHEMA material affects the transparency of the central optic due to the precipitation of material. In addition, the PHEMA material itself has a tendency to calcify, both with calcification of the PHEMA material itself and surface deposits of the central optic that can occur post-operatively. Journal "ophthalmology research" 2010, 6 th month, 28 th volume, 6 th paper "AlphaCor keratoprosthesis transplantation treatment rabbit corneal alkali burn" states that since the second stage of the operation of the AlphaCor keratoprosthesis 20 requires the excision of the poor corneal tissue above the central optical portion 201, the central optical portion 201 is lower than the surrounding anterior corneal lamella after the second stage of the operation, so that the central exposed area is more likely to generate fibroplasia, which affects the vision of the patient. In summary, the deficiencies of the AlphaCor keratoprosthesis 20 are mainly: (1) the implantation of the AlphaCor keratoprosthesis requires two operations, which is inconvenient for patients; (2) the artificial cornea skirt with the width less than 1.5mm is clamped and fixed by the front and back lamellar corneas of the receptor to form a centripetal tension, so that the artificial cornea is difficult to resist the external pushing force of the intraocular pressure on the artificial cornea, and the artificial cornea is easy to separate; (3) PHEMA material may affect the transparency of the central optic due to material deposition and tendency to self-calcify; (4) after the second stage of operation, the plane of the central optical part is lower than the plane of the peripheral corneal anterior lamina, so that the exposed central optical area is more easily subjected to secretion adhesion and anterior lamina implantation edge fibroplasia, and the vision of a patient is affected; (5) the AlphaCor keratoprosthesis has an overall diameter of 7.00mm (millimeter), is located in the center of the implant bed, is only 1/2 strong in the area of the whole receptor cornea, and has an opaque outer skirt portion which is, by contrast, significantly different from a normal cornea and is not beautiful and natural. (6) Glaucoma is caused. Since the AlphaCor artificial cornea implantation needs to use the receptor cornea which is mostly contracted and flattened due to pathological changes, when the artificial cornea is implanted between the front and back laminae, the anterior chamber angle is narrowed due to the influence of the receptor cornea-artificial cornea composite layer moving backwards, and the occurrence rate of glaucoma is increased.
Referring to fig. 3, fig. 3 is a schematic view of a prior art CorNeat keratoprosthesis 30. The CorNeat keratoprosthesis 30 includes a central optic 301 and a peripheral blend rim 302, and is attached to the central optic 301 at its peripheral overlap above the peripheral blend rim 302 by a non-degradable porous skirt 3021, interposed between the conjunctiva and sclera, in an attempt to ensure stability of the keratoprosthesis 30 after implantation in the human corneal tissue. The central optic 301 includes a recess 3011 and a hollow bow 3012 for securing the central optic 301 to the peripheral binding rim 302 after implantation of the CorNeat keratoprosthesis 30 into a subject. The central optic 301 extends rearwardly to form a recess 3011, the recess 3011 enabling the central optic 301 to snap into the annular incision in the cornea 500, the recess 3011 having a smooth surface. The peripheral skirt 302 faces the conjunctiva 600 (not shown), and the peripheral binding rim 302 has nanopores suitable for cell growth and collagen deposition for bio-integration. The CorNeat artificial cornea has the following defects: (1) the post-crenellated design used to prevent the outward protrusion of the keratoprosthesis 30 is a contact rather than a close fit between the keratoprosthesis 30 and the recipient cornea 500, the keratoprosthesis 30 is susceptible to rotational displacement by eyelid movement, and the recipient corneal posterior surface with which the post-crenellated design contacts is susceptible to erosion by the post-crenellated design resulting in edema and thawing of the graft. (2) The nanopores of the integrated skirt and the peripheral bonding edge are very small, so that the pores which can be seen under an optical or even electron microscope are long in time for biological integration, and the integrated tissues are not strong enough and cannot effectively fix the CorNeat artificial cornea; (3) the interface between the central optic 301 and the recipient cornea is smooth and prone to movement due to eye movements, the recipient cornea is subject to abrasion, and the gap between the two is thus enlarged, followed by aqueous humor leakage. (4) Although the central optic 301 is marked with an incision for performing an intraocular surgery at a later date, since the integrated skirt is dome-shaped, if another intraocular surgery is performed after the keratoprosthesis implantation, the incision must be made through the integrated skirt, inevitably destroying the non-dense corneal and scleral adhesions.
Referring to fig. 4, 5 and 6, fig. 4 is a schematic view of the components of a keratoprosthesis 40 according to the present invention; FIG. 5 is a schematic view of the central optic 401 of the components of the keratoprosthesis 40 of the present invention; figure 6 is a schematic view of an umbrella shaped wing 402 of the artificial cornea 40 of the present invention. In the present invention, the artificial cornea 40 includes two independent components, namely, a central optical portion 401 and an umbrella-shaped wing 402, and in the same operation, the central optical portion 401 is implanted into the corneal stroma of a recipient in a graft, and the umbrella-shaped wing 402 and the conjunctiva of the recipient are biologically integrated, so that the artificial cornea 40 is fixed. Specifically, in the present embodiment, the central optical portion 401 is a light-transmitting member and has diopter, and light outside the eyeball enters the eyeball through the central optical portion 401. In other embodiments, the central optic 401 has suitable optical power for the purpose of improving proper retinal imaging.
In the present invention, the center of the central optical portion 401 is a circular light-transmitting member, and the edge thereof includes at least two fixing legs 4012. If the number of the fixing legs 4012 is two, a connection line of the two fixing legs 4012 passes through a center of the circular light-transmitting portion 4011. In this embodiment, the number of the fixing legs 4012 is three, and the fixing legs are uniformly distributed on the circumference of the circular light-transmitting portion 4011. During operation, a circular hole with the same size as the circular light-transmitting part 4011 is formed on the receptor cornea 500, and the fixing feet 4012 are inserted into a stroma layer (the cornea 500 is not shown) of the receptor implant cornea 500, so that the central optical part 401 is fixed. By means of the fixation feet 4012, the outward escape of the central optical part 401 can be prevented, the rotary abrasion of the cornea 500 of the central optical part 401 can be prevented, and the generation of MMP (matrix metalloproteinase) induced eye diseases can be avoided. In another embodiment, the fixation feet 4012 of the central optic 401 are trapezoidal in shape. In the present invention, the arc length of the junction of the fixing foot 4012 and the circular light transmission section 4011 is shorter than the arc length of the side thereof away from the circular light transmission section 4011, and is called as a trapezoid. In other embodiments, the joint of the fixing foot 4012 and the circular light-transmitting portion 4011 is a straight line segment, the edge of the fixing foot 4012 on the side away from the circular light-transmitting portion 4011 is also a straight line segment, and when the two straight line segments are parallel, they are also called as a trapezoid. In the present invention, the fixing legs 4012 have a trapezoidal design, which is advantageous for suture fixation during surgery, and have a better effect of preventing the outward protrusion of the central optical portion 401 after being integrated with the cornea. Alternatively, the central optic 401 and fixation feet 4012 may be integrally formed, or the central optic 401 and fixation feet 4012 may be fixedly attached mechanically or chemically. Further, the length from the center of the circular light-transmitting part to the outer side edge of the fixing foot 4012 is not more than 5.5 millimeters (mm), in some embodiments, the fixing foot 4012 of the artificial cornea is made of a hard material, and the length is more than 5.5 mm, which may damage the angle structure, i.e., the aqueous humor circulation system at the corneal limbus, including trabecular meshwork, and the like, and further cause intraocular pressure abnormality, even glaucoma and the like. In another embodiment, each fixing foot 4012 has at least one fixing foot through hole 4014, after the cornea 500 is implanted, the cornea 500 is combined through the fixing foot through holes 4014, and the combination of the cornea combined in the through holes 4014 and the corneas on both sides of the cornea enables the central optical portion 401 to be fixed on the cornea 500 more firmly, so that the effects of preventing the central optical portion 401 from being pulled out and preventing the central optical portion 401 from rotating are well achieved.
In the present invention, the circular light-transmitting portion side surface 4013 of the center optical portion 401 is a rough surface. In this embodiment, the rough surface is a saw-tooth protrusion, and compared with the smooth surface adopted by the side surface 4013 of the circular light-transmitting portion, the rough surface can increase the area and the friction coefficient of the corneal tissue to which the corneal tissue is attached, and increase the friction force and the outward protruding resistance between the corneal tissue and the receptor, so that the circular light-transmitting portion 4011 and the corneal tissue are combined more tightly, the fixation of the circular light-transmitting portion 4011 and the cornea 500 is realized, and the function of preventing aqueous humor from leaking is also realized.
Referring to fig. 6, the center of the umbrella-shaped wing 402 is a circular hole 4021, which is disposed opposite to the circular light-transmitting portion 4011, and the diameter of the circular hole 4021 is smaller than or equal to the diameter of the circular light-transmitting portion 4011. For example, the diameter of the central circular hole 4021 of the umbrella wing is equal to the diameter of the circular light-transmitting portion 4011, and the circular light-transmitting portion 4011 is placed in the central circular hole 4021 and is connected with the central circular hole 4021 in a seamless manner for 360 degrees, so that aqueous humor leakage is prevented. Preferably, the diameter of the central circular hole is 8.0 mm (mm) to 8.5 mm (mm), it can be understood that the diameter of the corresponding circular light transmission part 4011 is also 8.0 mm (mm) to 8.5 mm (mm), the diameter of the circular light transmission part 4011 is large, the diameter is close to the average cornea diameter of 11.0 mm (mm) of an adult, after the circular light transmission part 4011 is implanted into a corneal stroma of a receptor, the appearance is more natural, and the stronger the intraocular pressure born by the circular light transmission part 4011 is, the stronger the fixation strength with the corneal stroma is improved. Outside the circular aperture 4021 of the umbrella shaped wing 402 is an annular leak protection zone 4022, it being understood that the annular leak protection zone 4022 extends 360 ° outward from the junction of the circular aperture 4021 and the circular light transmissive portion 4011, preferably, the annular zone is formed to have a width of 1.5 millimeters (mm) to 2.0 millimeters (mm), the outer circumferential edge of the annular leak protection zone 4022 exceeds the receptor limbus, more particularly, 0.5 millimeters (mm) to 1.0 millimeters (mm), it being understood that since the circular light transmissive portion 4011 is in intimate contact with the receptor cornea 500, a junction exists where the outer circumferential edge of the annular leak protection zone 4022 exceeds the receptor limbus, the area of the annular leak protection zone 4022 covers and exceeds the junction, further preventing aqueous humor within the eye from leaking from the junction to the outside of the eye, and for this reason, the annular leak protection zone 4022 is dense and void-free.
Further, the outer side of the annular anti-leak region 4022 includes at least two wings 4023, the wings 4023 are disposed between the conjunctiva and the sclera during operation, in some embodiments, the number of the wings 4023 is 4, the wings are uniformly distributed on the circumference of the same circle center as the circular central hole 4021 of the umbrella-shaped wing in a cross shape perpendicular to the center of the whole umbrella-shaped wing 402, the wings 4023 include a bio-integration region for bio-integration with the conjunctiva, and specifically, the integration region of the wings 4023 is uniformly distributed with the micro holes 4024. In histology, the conjunctiva is divided into an epithelial layer and a submucosal layer. The repair of the conjunctiva stroma after the injury is mostly accompanied with the growth of new blood vessels, the superficial conjunctiva layer is composed of loose tissues, and the conjunctiva stroma cannot be restored to the original state after the injury; after deep tissue repair, fibroblasts proliferate excessively, secreting collagen to adhere conjunctival tissue to the sclera, thereby forming scars. Therefore, the wing 4023 stimulates conjunctival cells to secrete collagen between the conjunctiva and the sclera, and the proliferated fibrous tissue directly penetrates through the pores of the wing 4023 to weave a dense omnidirectional three-dimensional fibrous reticular structure, i.e., the bio-integration process, thereby forming resistance against the exophthalmos of the artificial cornea and preventing the central optical portion 401 inside the umbrella-shaped wing 402 from protruding outwards. It should be noted that if the micropores 4024 are small, the time for the bio-integration process is long and the tissue resulting from the integration is not strong enough to affect the fixation of the keratoprosthesis, preferably the micropores 4024 are greater than 20 microns (μm) in diameter.
Further, considering that complications or other eye diseases may occur after the keratoprosthesis implantation operation, an inner eye operation is required, and the dome region between two adjacent wings 4023 is a surgical reserve 4025 as an approach for the inner eye operation without breaking the umbrella wings 402. It will be appreciated that since there are at least 2 wings 4023, there are at least 2 corresponding surgical reserves 4025, located in additional quadrants including the superotemporal and inferotemporal quadrants. In general, due to different dominant hand of the main surgeon, even if the position of one surgical reserve 4025 is not suitable for surgical access, the other adjacent surgical reserve 4025 can be used for surgical access without destroying the overall structure of the umbrella-shaped wing 402. It should be noted that the edge of the operation reserved area 4025 close to the corneal limbus does not exceed the outer edge of the annular leakage-proof area 4022, and it can be understood that the operation reserved area 4025 does not damage the compact structure of the annular leakage-proof area 4022, and thus the leakage-proof function is not affected, otherwise the aqueous humor in the eye may leak out of the eye from the damaged annular leakage-proof area 4022, and the intraocular pressure is affected or the eye diseases are caused. The umbrella-shaped wing 402 of the artificial cornea can be folded and placed on the outer surface of the central optical part 401 to facilitate the implantation operation, and after the fixing foot 4012 is inserted into the donor corneal stroma, the natural state of the umbrella-shaped wing before folding can be restored. Specifically, referring to fig. 4, the large area of the umbrella wings 402, when placed naturally, covers the central optic 401 and support legs 4011, which may interfere with the intraoperative proper positioning of the artificial cornea 40. Therefore, in positioning the central optical portion 401 and the supporting legs 4011, the umbrella wings 402 are folded and placed on the outer surface of the central optical portion 401, and after the central optical portion 401 and the supporting legs are positioned and correctly placed in the recipient corneal stroma, the umbrella wings are restored to the natural state before folding.
It should be noted that the annular leakage preventing region 4022, the circular hole, the wing 4023 and the operation reserving region 4025 are all components of the umbrella-shaped wing 402, and the whole umbrella-shaped wing 402 is divided according to the functions of each region.
It should be noted that, in the foregoing embodiment, each included module is only divided according to functional logic, but is not limited to the above division as long as the corresponding function can be implemented; in addition, specific names of the functional units are only for convenience of distinguishing from each other, and are not used for limiting the protection scope of the present invention. The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents and improvements made within the spirit and principle of the present invention are intended to be included within the scope of the present invention.
Claims (10)
1. A keratoprosthesis, comprising: a central optic portion and an umbrella wing;
the central optical part is a circular light-transmitting part, and the side surface of the central optical part is a rough surface;
the edge of the central optical part comprises at least two fixing feet, and the fixing feet are used for being inserted into corneal stroma of the implantation bed to realize the functions of fixing the central optical part and preventing the central optical part from being separated;
the center of the umbrella-shaped wing is a round hole and is used for being arranged opposite to the circular light-transmitting part, and the diameter of the round hole at the center of the umbrella-shaped wing is smaller than or equal to that of the circular light-transmitting part;
the outer side of the central circular hole of the umbrella-shaped wing is provided with an annular leakage-proof area;
the outer side of the umbrella-shaped wing annular leakage-proof area comprises at least two side wings, and the side wings comprise biological integration areas for biological integration with the conjunctiva.
2. The keratoprosthesis of claim 1, wherein the fixation legs of the central optic are trapezoidal in shape and have a shorter arc length at the junction with the circular light-transmitting portion than at the side thereof remote from the circular light-transmitting portion.
3. The keratoprosthesis of claim 2, wherein the fixation legs of the central optic have through holes.
4. The artificial cornea of claim 3, wherein said annular leakage prevention zone has an outer circumferential edge that exceeds the recipient limbus, and wherein said leakage prevention zone is dense and non-porous.
5. The keratoprosthesis of claim 4, wherein the bio-integration region of the flap has pores with a diameter greater than 20 microns (μm).
6. The artificial cornea of any one of claims 2 to 5, wherein the space between two adjacent wings is a surgical reserve, and the edge of the surgical reserve on the side close to the limbus does not exceed the outer circumferential edge of the annular leakage-preventing region.
7. The keratoprosthesis of claim 6, wherein the diameter of the circular hole in the center of the umbrella wings is 8.0 millimeters (mm) to 8.5 mm.
8. The artificial cornea as claimed in claim 7, wherein the number of the fixing legs of the central optical portion is three, and the three fixing legs are uniformly distributed on the circumference of the same circle center as the circular light-transmitting portion; the number of the side wings on the outer side of the annular leakage-proof area is four, and the four side wings are uniformly distributed on the circumference of the same circle center as the central circular hole of the umbrella-shaped wing.
9. The keratoprosthesis of claim 8, wherein a length from a center of the circular light-transmitting portion to an outer edge of the fixation leg is no more than 5.5 millimeters (mm).
10. The keratoprosthesis of claim 9, wherein said umbrella wings are adapted to be folded over the anterior surface of said central optic portion and return to a spherical shape after insertion of the fixation legs of said central optic portion into the implantation matrix during surgery.
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| CN202010148167.8A CN111419471A (en) | 2020-03-05 | 2020-03-05 | Artificial cornea |
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| CN113599020A (en) * | 2021-09-15 | 2021-11-05 | 姚晓明 | Artificial cornea integrating refractive function of crystalline lens |
| CN113786268A (en) * | 2021-08-27 | 2021-12-14 | 广东佳悦美视生物科技有限公司 | II-type collar button type artificial cornea |
| WO2023098143A1 (en) * | 2021-12-02 | 2023-06-08 | 北京米赫医疗器械有限责任公司 | Artificial cornea based on umbrella-shaped cylinder, and preparation process therefor |
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