CN111249034A - Posterior sclera reinforcing structure capable of developing under nuclear magnetic resonance - Google Patents
Posterior sclera reinforcing structure capable of developing under nuclear magnetic resonance Download PDFInfo
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- CN111249034A CN111249034A CN202010244359.9A CN202010244359A CN111249034A CN 111249034 A CN111249034 A CN 111249034A CN 202010244359 A CN202010244359 A CN 202010244359A CN 111249034 A CN111249034 A CN 111249034A
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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
- A61F2/147—Implants to be inserted in the stroma for refractive correction, e.g. ring-like implants
Abstract
The invention provides a posterior sclera reinforcing structure capable of developing under nuclear magnetic resonance, which comprises a main body structure and a developing structure, wherein the developing structure is arranged on the main body structure and is integrated with the main body structure, the developing structure is a hollow structure, the shell wall of the developing structure is impermeable, and a developing agent capable of developing under nuclear magnetic resonance is filled in an inner cavity and is used for easily observing the shape and the position of the main body structure under the nuclear magnetic resonance, so that the post-operation review and the inspection are facilitated, and the evaluation on the operation effect by medical staff is facilitated. The material has good biocompatibility, proper elasticity and tensile strength and is not easy to absorb, so that the operation effect is long-term effective, and the requirement of posterior sclera reinforcement treatment is met.
Description
Technical Field
The invention generally relates to the technical field of ophthalmic disease treatment equipment, and particularly relates to a developable posterior sclera reinforcing structure which is used for clearly observing the reinforcing structure under nuclear magnetic resonance.
Background
High myopia is also called pathological myopia and is a common blindness-causing eye disease, and various pathological changes such as retinal detachment, high myopia macular degeneration, retinal choroidal atrophy, posterior scleral staphyloma, paint cracks, Fuch's spots and the like can occur, so that the visual function is seriously damaged. China is one of the countries with the highest incidence rate of myopia in the world, the incidence rate is 70-90%, and meanwhile, the incidence rate of high myopia in China is very high, the investigation of middle school students in the western region of China in 2015 shows that the incidence rate of high myopia is (2.9 +/-0.4%), the investigation of middle school students above 17 years old reaches (9.9 +/-3.0%), and the statistics of university students in Shanghai in 2012 show that the incidence rate of high myopia reaches 19.5%. Serious complications occur in 61.7 percent of people with high myopia, and especially, 100 percent of people with high myopia have macular degeneration when the myopia degree is > -10.0D, so that the vision of patients is remarkably reduced until blindness, the quality of life of tens of millions of Chinese people is remarkably reduced, and a large amount of social resources are consumed.
The pathogenesis of the complications of high myopia is still not completely understood, and most scholars consider the relationship with genetic inheritance and acquired environmental factors, and regarding their possible pathological mechanisms, most scholars consider the most prominent pathological features to be ocular axis elongation and posterior scleral staphyloma. There is currently no satisfactory explanation for the mechanism of ocular axis elongation and posterior scleral staphyloma. The mechanical characteristics and defects of the scleral wall are considered to be one of important factors, because from the mechanical properties of the three-layer structure of the eyeball wall, the tangential moduli of the three are sequentially higher by one order of magnitude from the retina to the sclera under the same stress level, so that the sclera plays a key role in maintaining the shape of the eyeball.
There is no mature method for treating pathological myopia, most of patients with pathological myopia adopt corrective prescription by means of spectacle matching, LASIK operation and intraocular lens implantation with lens, but the problems that the axis of the eye is prolonged year by year, the degree of the eye is increased year by year and various complications are gradually caused cannot be fundamentally solved. In the expert consensus on high myopia prevention and control, which was published in 2017 by the ophthalmology division ophthalmology optical group of the Chinese medical society, the posterior sclera reinforcement is definitely proposed, so that the further increase or shortening of the front and back axes of the eye can be effectively prevented, and macular cleavage and retinal cleavage can be treated by combining lens or vitreous body surgery. The main mechanism of the posterior scleral reinforcement for treating the pathological myopia is to reinforce the weak sclera at the back of the eyeball of the pathological myopia through an implant, strengthen the strength of the posterior sclera through physical reinforcement, inflammatory reaction, scar formation and the like, prevent the axis of the eye from being further prolonged, and finally achieve the purpose of preventing the visual function from being further deteriorated. The operation has been for decades, and there are many reports at home and abroad, but the operation still has certain problems at present, for example, the posterior sclera reinforcing material is usually made of biological material, and the biological material is easily absorbed and degraded after the operation, which causes the operation effect to be difficult to ensure and maintain. In addition, the existing posterior scleral reinforcement researches are all based on reinforcing structural materials, and are all based on biological materials such as allogenic sclera, allogenic sclera and allogenic pericardium, for example, a biological membrane material strip for a posterior scleral reinforcement surgery with high myopia and a manufacturing method thereof disclosed in the prior chinese patent CN102525729B, a biological sclera contraction band and a manufacturing method thereof disclosed in the chinese patent CN103948469B, and a biological patch for the posterior scleral reinforcement surgery and a manufacturing method thereof disclosed in the chinese patent application CN110353856A are all modified and processed on the basis of biological materials, and the problem that the biological materials are absorbed and degraded in the long term after the surgery is not solved.
Disclosure of Invention
In view of the defects of the prior art, the invention aims to design a posterior sclera reinforcing structure which can be clearly observed by nuclear magnetic resonance after operation under the condition of meeting the inherent functional attributes of the posterior sclera reinforcing structure, and is convenient for the review after operation and the evaluation of the operation effect. The material has good biocompatibility, proper elasticity, creep rate and tensile strength, is not easy to absorb, ensures that the operation effect is long-term effective, and meets the requirements of posterior sclera reinforcement treatment.
The technical scheme of the invention is as follows: the invention provides a posterior sclera reinforcing structure capable of developing under nuclear magnetic resonance, which comprises a main body structure and a developing structure, wherein,
the main body structure is used for reinforcing the back sclera and is a polyester structure made of polyethylene terephthalate fiber, the elastic modulus of the polyester structure is 1.0-1.5Mpa, the 1-hour creep rate is 0.01-0.2%, the ultimate stress is 50-100Mpa, and the polyester structure material can not absorb;
the developing structure is arranged on the main body structure and comprises a polyester shell made of polyethylene terephthalate fibers, the wall of the shell is impermeable, a hollow sealed inner cavity is formed inside the shell, and a developing agent which can be developed under nuclear magnetic resonance is filled in the inner cavity.
The development structure can be clearly observed by nuclear magnetic resonance after operation, the main body structure made of polyethylene terephthalate fiber solves the problem that the biomaterial is absorbed and degraded in the long term after operation under the condition of meeting the inherent functional attributes of the posterior sclera reinforcing structure, the combination of the two means is convenient for the postoperative reexamination of the reinforcing structure and the evaluation of the operation effect, and the postoperative reexamination requirement of the operation is greatly met.
As an improvement of the invention, the terylene structure is in a strip shape, a Y shape or a special shape; the strip thickness of the strip-shaped terylene structure is 0.2-1mm, and the width is 4-6 mm; the thickness of each Y-shaped branch of the Y-shaped terylene structure is 0.2-1mm, the width is 4-6mm, and the included angle between Y characters is 30-60 degrees; the thickness of the special-shaped polyester structure is 0.2-1mm, and the width of the special-shaped area is 4-6 mm.
The strip-shaped structure meets the requirements of most operations, the Y-shaped and other special-shaped designs can also meet the requirements of special conditions of part of patients, and the size design of the terylene structure fully considers the eye structural characteristics of the patients in the actual operation, so that the terylene structure has better practicability.
As an improvement of the invention, the strip-shaped terylene structure has a wide middle strip and gradually narrows towards two ends.
As an improvement of the invention, the overall length of the terylene structure is not more than 100 mm. Considering the axial characteristics of the eyes of the patient with pathological myopia, the length of 100mm is enough to deal with the axial characteristics, and the redundant part can be cut individually during the operation.
As an improvement of the invention, the developing structure is a hollow terylene developing tube made of polyethylene terephthalate fiber, the outer diameter of the developing tube is 0.4-1mm, the inner diameter of the developing tube is 0.2-0.5mm, the length of the developing tube is 30-60mm, and the two ends of the hollow terylene developing tube are closed and filled with the developer; preferably, the length of the hollow terylene developing tube is 50 mm.
The size design of the developing tube fully considers the limit requirements of the processing and manufacturing process and the feasibility of filling the developer, and also considers the feasibility of fixing on the main body structure, so that the realization of the technology is ensured.
As an improvement of the invention, the pipe wall of the hollow terylene development pipe is designed into a watertight structure by adopting a textile process.
As an improvement of the invention, the cross section of the hollow terylene development tube is in a shape of circle, ellipse, square, rectangle or other polygons.
As an improvement of the invention, at least one hollow terylene developing tube is arranged and distributed at the appointed position of the main body structure; preferably, the two hollow terylene development tubes are symmetrically distributed on the edges of two sides of the main body structure.
As an improvement of the invention, the hollow terylene developing tube is integrally woven with the main structure or fixed on the main structure by pasting or sewing with a suture.
As an improvement of the invention, the developing agent is water, sodium hyaluronate, gadolinium developing agent or other materials which can be obviously distinguished from the eyeball wall and the intraorbital fat tissue in the nuclear magnetic resonance T2 phase.
Compared with the prior art, the invention has the beneficial effects that: the posterior sclera reinforcing structure provided by the invention can be clearly observed by nuclear magnetic resonance after operation under the condition of meeting the inherent functional attributes of the posterior sclera reinforcing structure, and is convenient for the post-operation review and the evaluation of the operation effect. The invention has at least the following concrete practical effects:
(1) the elastic modulus of the strip-shaped polyester structure is close to that of the sclera of a human body, so that the reinforcing material can be attached to the eyeball as soon as possible in the initial operation stage, the operation effect can be maintained for a long time due to low creep rate without failure caused by deformation of the reinforcing material of the posterior sclera, the high ultimate strength has better deformation resistance, the eyeball is protected, and the performance of the reinforcing structure can better meet the clinical requirement of the reinforcing material of the posterior sclera;
(2) the polyester material has good biocompatibility and is not easy to absorb, and the long-term effective operation effect can be ensured;
(3) the size and the shape of the strip fully consider the structural characteristics of eyeballs, so that the strip is convenient to use in actual operation and can practically achieve the reinforcing effect on pathological areas;
(4) the developing structure is made into a tubular structure, so that the developer is convenient to fill, and the developing structure is not easy to damage in the using process; the waterproof property of the developing structure can lead the developer to be sealed in the developing structure for a long time, thus leading the developing structure to have a long-term developing function.
(5) The tubular structure is easier to operate when being fixed on the main body structure, the arrangement on the main body structure is more flexible, and the development is clearer and more complete;
(6) the main structure can be individualized and cut out in the use, and the developing tube also can make the long tube and then individualized and cut out and seal both ends as required in the manufacturing process, uses more in a flexible way.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below. It should be apparent that the drawings in the following description are merely exemplary, and that other embodiments can be derived from the drawings provided by those of ordinary skill in the art without inventive effort.
The structures, ratios, sizes, and the like shown in the present specification are only used for matching with the contents disclosed in the specification, so as to be understood and read by those skilled in the art, and are not used to limit the conditions that the present invention can be implemented, so that the present invention has no technical significance, and any structural modifications, changes in the ratio relationship, or adjustments of the sizes, without affecting the effects and the achievable by the present invention, should still fall within the range that the technical contents disclosed in the present invention can cover.
FIG. 1 is a schematic plan view of one embodiment of a reinforcing structure of the present invention;
FIG. 2 is a schematic perspective view of one embodiment of a reinforcing structure of the present invention;
FIG. 3 is a schematic side view of one embodiment of a reinforcing structure of the present invention;
FIG. 4 is a schematic plan view of another embodiment of a reinforcing structure of the present invention;
FIG. 5 is a schematic illustration of one embodiment of the development configuration of the present invention;
FIGS. 6 to 9 are schematic structural views of different embodiments of the developing tube of the present invention;
fig. 10 is a comparison diagram of clinical use states of a reinforcing structure according to the present invention, wherein (a) is a diagram illustrating preoperative eyeball examination of a patient, (b) is a diagram illustrating postoperative eyeball examination of a patient using a reinforcing structure according to the present invention, and (c) is a diagram illustrating postoperative eyeball examination of a conventional reinforcing structure.
The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this application, illustrate embodiment(s) of the invention and together with the description serve to explain the principles of the invention.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the embodiments of the present invention are described in further detail below with reference to the embodiments and the accompanying drawings. The exemplary embodiments and descriptions of the present invention are provided to explain the present invention, but not to limit the present invention.
In the description of the present invention, it is to be understood that the terms "comprises/comprising," "consists of … …," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a product, apparatus, process, or method that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such product, apparatus, process, or method if desired. Without further limitation, an element defined by the phrases "comprising/including … …," "consisting of … …," or "comprising" does not exclude the presence of other like elements in a product, device, process, or method that comprises the element.
It will be further understood that the terms "upper," "lower," "front," "rear," "left," "right," "top," "bottom," "inner," "outer," and the like, refer to an orientation or positional relationship illustrated in the drawings for convenience in describing the present invention and to simplify description, and do not indicate or imply that the referenced device, component, or structure must have a particular orientation, be constructed in a particular orientation, or be operated in a particular manner, and should not be construed as limiting the present invention.
Referring to fig. 1 to 3, an embodiment of the present invention firstly provides a posterior sclera reinforcement structure capable of being developed under nuclear magnetic resonance, including a main body structure 1 and a development structure 2 disposed on the main body structure, where the main body structure 1 is used to reinforce the posterior sclera, and the development structure 2 is a hollow structure, and is filled with a developer for nuclear magnetic resonance, and is used for developing a main body structure material under nuclear magnetic resonance, so that the shape and position of the main body structure can be easily observed, thereby facilitating the review and inspection after operation, and facilitating the evaluation of the operation effect by medical staff.
As an embodiment, the main body structure 1 is a strip-shaped polyester structure made of polyethylene terephthalate fibers, the thickness of the strip is 0.2-1mm, the width of the strip is 4-6mm, and the length of the strip is not more than 100 mm; the developing structure 2 comprises a terylene shell made of polyethylene terephthalate fiber, the wall of the shell is impermeable to water, a hollow sealed inner cavity is formed inside the shell, and a developer for nuclear magnetic resonance is filled in the inner cavity.
The strip-shaped dacron structure or dacron sheet has the elastic modulus of 1.0-1.5MPa (the elastic modulus of human sclera is about 1.15MPa), the 1-hour creep rate of 0.01-0.2% (the 1-hour creep rate of human sclera is 1.4%), and the ultimate stress of 50-100MPa (the ultimate stress of human sclera is 0.3 MPa). The elastic modulus close to that of the human sclera ensures that the posterior sclera reinforcing material can be attached to the eyeball as soon as possible in the early stage of the operation, so that the reinforcing effect cannot be achieved due to the low elastic modulus, and the wrinkles of local compression depression cannot be caused due to the high elastic modulus. The significantly lower creep rate allows the surgical effect to be maintained for a longer period of time without failure due to deformation of the posterior scleral reinforcement material. The higher ultimate strength indicates that the posterior sclera reinforcing material has better anti-deformation capability, can ensure the eyeball deformation of a protected area even if being impacted by larger instantaneous force, and has additional eyeball protection function. The invention fully considers the physical and mechanical characteristics of the polyester material, so that the performance of the reinforced structure can better meet the clinical requirements of the posterior sclera reinforced material.
The invention selects the polyester band or the polyester sheet made of the polyethylene terephthalate fiber, except the mechanical properties mentioned above, the material has good biocompatibility, and has been applied in clinical multiple subjects at present, such as being used as a pericardium patch to be implanted into a body to treat congenital ventricular defect and atrial defect, being used as a matrix material to repair trachea, being used as an artificial material to repair abdominal wall defect, being used for preparing artificial ligament with diameter, and even being made into artificial dura mater to repair meninges. Although no studies have been found concerning the use of such a structure for surgical treatment of the eye, in particular for reinforcement of the posterior sclera, the above clinical applications have demonstrated that the material has good biocompatibility as required for posterior scleral reinforcement.
In addition, the polyester tape or the polyester sheet made of the polyethylene terephthalate fiber has mature production process, is easy to obtain, can ensure the manufacturing and forming under the condition of such fine size, achieves the expected effect, has low cost, is beneficial to reducing the production cost, reduces the medical expense of patients and reduces the medical expenditure for the society.
Therefore, just in view of the material characteristics of the dacron sheet made of the polyethylene terephthalate fiber, the dacron sheet can better meet the clinical requirements of posterior scleral reinforcement, and the human body implant has long-term existence, does not absorb and dissolve and is highly consistent with the lifetime effect required by posterior scleral reinforcement.
The main structure 1 has the strip thickness of 0.2-1mm, the width of 4-6mm and the length of 100mm, the design length is longer, the individual cutting is carried out according to the requirement when in specific use, the width design considers that the posterior sclera reinforcing material is required to be placed between the inferior oblique muscle and the optic nerve in the operation, 2.2mm behind the posterior end of the inferior oblique muscle is a macular area, namely, the central position of pathological myopia lesion, which is the most hopeful position for reinforcing the operation, and 5mm behind the posterior end of the inferior oblique muscle is the optic nerve, although the length of the eye support is generally larger than 5mm in pathological myopia patients, but rarely exceeds 6mm, the length of the eye support is designed to be 4mm-6mm, and the length of the eye support is designed to be 100mm because the axis of the eye of the pathological myopia patients is longer, often about 30mm, therefore, 100mm can be sufficiently used under the requirement that the operation needs 3/4 weeks for fixation, and the redundant parts can be cut individually during the operation.
Referring to fig. 4, as an embodiment, the main body structure is designed into a Y-shaped terylene structure, the thickness of each branch of the Y shape is 0.2-1mm, the width is 4-6mm, the included angle theta between Y-shaped characters is 30-60 degrees, and the integral length is not more than 100 mm. The Y-shaped design considers that the position of the retroscleral staphyloma of part of patients is not limited to a macular region or may occur in an optic nerve nasal side region, the Y-shaped design covers both the macular region and the optic nerve region, and the design can be individually designed and selected according to the preoperative 3D-MRI of the patient during specific use.
Theoretically, the shape of the main structure of the invention can be adjusted according to the needs and directly processed and woven into any shape, and also can be made into a large sheet for cutting, such as a sheet with 100mm by 200mm, and personalized cutting is carried out when in use. However, the sheet can be made into any plane shape such as a strip shape, especially a Y shape and a special shape no matter the sheet is directly processed or is cut in a large sheet later stage.
Referring to fig. 5, as an embodiment, the developing structure 2 of the present invention is a hollow polyester developing tube made of polyethylene terephthalate fiber, which has a tube wall 21, an outer diameter of 0.4 to 1mm, an inner diameter of 0.2 to 0.5mm, and a length of 30 to 60mm, and both ends 22 of the hollow polyester developing tube are closed, and the tube is filled with a developer for nuclear magnetic resonance (not shown in the figure).
The developing structure is made into a tubular structure, the tubular structure can be used for conveniently filling liquid, two ends of the tubular structure are easy to seal, and compared with a planar structure, the tubular structure is not easy to damage in the using process, the damage rate in the product manufacturing process can be reduced, and the perfectness rate in the using process can be improved.
The tubular structure is easier to handle when fixed on the main structure, the fixing can be realized more easily no matter whether the tubular structure is pasted or sewed, the tubular structure is easier to arrange on the main structure, and the outline shape of the reinforced structure is easier to show when in operation imaging.
The length of the tube can be random theoretically, and the length can be cut according to the requirement of the main structure during processing and manufacturing, for example, the length is 50 mm. The length of the developing structure is designed to be 30mm-60mm, not 100mm which is the same as the length of the main structure, because the main structure is generally cut and removed when being used specifically, if the main structure is the same length, the tube wall of the developing material can be cut to cause the developer to run off, although the developer is harmless, the developing failure can be caused, the developing at the central position of 30mm-60mm is enough to display the outline of the main structure and the position of surgical implantation after surgery, and therefore the influence of the developing structure on various mechanical properties of the main structure can be reduced as much as possible.
The hollow polyester developing tube made of the polyethylene terephthalate fibers is soft in texture, the tube body can be bent at will as shown in fig. 5, and the tube body can be bent at will according to the shape of the main structure, so that the tube body is convenient to adapt to the shape of the main structure.
The tube wall is designed to be waterproof according to a textile process, and a developing agent for nuclear magnetic resonance is filled in the hollow terylene developing tube, and comprises water, sodium hyaluronate, gadolinium developing agent or other materials which can be obviously distinguished from the eyeball wall and the intraorbital adipose tissue in a nuclear magnetic resonance T2 phase. After filling, both ends are sealed to reach the watertight degree.
The terylene developing tube does not develop under the nuclear magnetic resonance, but the developing agent filled in the terylene developing tube can develop and is obviously different from eyeballs and surrounding tissues, so that the terylene developing tube realizes the developing function under the magnetic resonance. The unique design is as follows: after performing orbital examination by nuclear magnetic resonance examination, data of a T2 phase is generally used in a 3D-MRI reconstruction process, and orbital tissue is characterized in that high signals are generated in the inner part of an eyeball, low signals are generated on the wall of the eyeball and high signals are generated on the outer part of the eyeball, particularly on fat tissues between the back of the eyeball and an orbital bone when the orbital tissue is in the T2 phase. The material which can be obviously distinguished from the low signal of the eyeball wall and the high signal of the fat tissue is needed, and the self-body or variant biological material reported in the posterior scleral reinforcement operation and the artificial synthetic material such as terylene adopted by the main body structure of the invention do not have the function. The common medical metal materials do not have the function. The developing agent for nuclear magnetic resonance of water, sodium hyaluronate and gadolinium has ultrahigh signals which are tens to hundreds times higher than signals of adipose tissues, so that the terylene developing tube designed by the invention has good biocompatibility, and can ensure that the posterior sclera reinforcing material is obviously distinguished from the wall and fat of an eyeball under nuclear magnetic resonance, and finally the purpose of clearly developing the posterior sclera reinforcing material under 3D-MRI is realized.
Referring to fig. 6 to 9, as an embodiment, the hollow polyester developing tube of the present invention may be manufactured to have a cross section in a shape of a circle, an ellipse, a square, a rectangle, or other polygonal shapes, and is flexibly selected according to a processing process, tube body strengths of different cross sections, and a weaving process with a main body structure.
Referring to fig. 1 and 4, as an embodiment, two hollow polyester developing tubes are arranged and symmetrically distributed on the edge of the main body structure. Two hollow polyester developing tubes are symmetrically arranged at the edge of the main body structure, so that the whole outline edge of the main body structure can be clearly displayed, and the imaging effect is more complete and real during nuclear magnetic resonance examination. Of course, one hollow terylene developing tube can be arranged and distributed at the appointed position of the main body structure, as long as the developing effect can be achieved.
The main structure and the developing structure are integrated, the method comprises the step of directly weaving the developing structure at the frame position or the designated position when weaving the rear sclera reinforcing main structure, and the step of respectively manufacturing the developing structure and the rear sclera reinforcing main structure and fixing the developing structure at the designated position of the main structure by using suture, adhesion and other modes.
The position where the developing structure is fixed is mostly the edge of the main structure, and may be the center of the main structure or an arbitrary position, and does not cover the entire area.
The use method of the reinforced structure comprises the following steps:
the method comprises the steps of carrying out preoperative examination on a patient, determining that the patient needs to carry out posterior sclera reinforcement surgery, carrying out 3D-MRI examination on the patient before the surgery, determining the width, the shape and the like required by a posterior sclera reinforcement material, carrying out posterior sclera reinforcement surgery, implanting the posterior sclera reinforcement structure which can be developed under nuclear magnetic resonance in the surgery, carrying out 3D-MRI examination again after the surgery, observing whether the shape of the posterior sclera reinforcement structure is complete and the position is in the surgery design position, so as to evaluate whether the surgery is successful or not, and evaluating the surgery effect through long-term follow-up 3D-MRI examination after the surgery.
Referring to fig. 10, the post-operative effect of using the reinforcement structure of the present invention was verified in connection with clinical surgery:
the patient Wangzhi, male, age 35, diagnosed as pathologic myopia of both eyes, retinal cleavage of both eyes, examined that the best corrected vision is right: -17.5DS-0.75DC 125 ═ 0.5, left: 18.0DS-0.50DC 150 ═ 0.4, axial length right 28.5mm, left 29.0mm, and preoperative 3D-MRI indicated posterior scleral staphyloma in the right eye, as shown in fig. 10 (a). After sufficient preoperative examination and communication, a binocular posterior scleral reinforcement surgery was performed and the developable posterior scleral reinforcement structure of the present invention was implanted. And 3D-MRI examination is carried out on the right eye after 1 week of operation, as shown in fig. 10(b), the implanted dacron strip is positioned at the operation design position, the outline is clearly developed, the effect after the operation is healed is evaluated well, and the 3D-MRI examination is carried out again after half-year follow-up after the operation to find that the implanted reinforcing structure is still positioned at the operation design position. The patient is initially judged to be good after the treatment, and the satisfaction degree of the patient is higher.
In contrast, the conventional reinforcing structure, without the developing structure of the present invention implanted, the reinforcing structure body, i.e., the main structure corresponding to the present invention, cannot be clearly developed under 3D-MRI examination, as shown in fig. 10(c), which cannot achieve the purpose of post-operative review and evaluation of the effect of the operation,
through the improvement of the invention, the posterior sclera reinforcement structure can be observed by doctors after operation, the collection and analysis of clinical data are substantially promoted, the evaluation of clinical effect is facilitated, the development of posterior sclera reinforcement operation is finally promoted, and a reliable selection is provided for the high myopia encountered in clinic, so that the pathological high myopia patients in the national and global range have new treatment hope, the occurrence of blindness is reduced, and the social benefit is higher.
Thus, it should be understood by those skilled in the art that while exemplary embodiments of the present invention have been illustrated and described in detail herein, many other variations and modifications can be made, which are consistent with the principles of the invention, from the disclosure herein, without departing from the spirit and scope of the invention. Accordingly, the scope of the invention should be understood and interpreted to cover all such other variations or modifications.
Claims (10)
1. A posterior sclera reinforcing structure capable of developing under nuclear magnetic resonance comprises a main body structure and a developing structure, wherein,
the main body structure is used for reinforcing the back sclera and is a polyester structure made of polyethylene terephthalate fiber, the polyester structure is not absorbable, the elastic modulus is 1.0-1.5Mpa, the 1-hour creep rate is 0.01-0.2%, and the ultimate stress is 50-100 Mpa;
the developing structure is arranged on the main body structure and comprises a polyester shell made of polyethylene terephthalate fibers, the wall of the shell is impermeable, a hollow sealed inner cavity is formed inside the shell, and a developing agent which can be developed under nuclear magnetic resonance is filled in the inner cavity.
2. The posterior scleral reinforcement structure of claim 1, wherein the dacron structure is in the shape of a strip, a Y-shape, or a profile; the strip thickness of the strip-shaped terylene structure is 0.2-1mm, and the width is 4-6 mm; the thickness of each Y-shaped branch of the Y-shaped terylene structure is 0.2-1mm, the width is 4-6mm, and the included angle between Y characters is 30-60 degrees; the thickness of the special-shaped polyester structure is 0.2-1mm, and the width of the special-shaped area is 4-6 mm.
3. The posterior scleral reinforcement structure of claim 2, wherein the ribbon of the ribbon-like dacron structure is wide in the middle and gradually narrows towards the ends.
4. The posterior scleral reinforcement structure of claim 2, wherein the dacron structure has an overall length of no more than 100 mm.
5. The posterior sclera reinforcement structure of any one of claims 1 to 4, wherein the visualization structure is a hollow terylene visualization tube made of polyethylene terephthalate fiber, the hollow terylene visualization tube has an outer diameter of 0.4 to 1mm, an inner diameter of 0.2 to 0.5mm and a length of 30 to 60mm, and both ends of the hollow terylene visualization tube are closed, and the tube is filled with the visualization agent; preferably, the length of the hollow terylene developing tube is 50 mm.
6. The posterior scleral reinforcement structure of claim 5, wherein the wall of the hollow dacron visualization tube is designed to be watertight using a textile process.
7. The posterior scleral reinforcement structure of claim 5, wherein the hollow dacron visualization tube is circular, elliptical, square, rectangular or other polygonal shape in cross-section.
8. The posterior sclera reinforcement structure of claim 5, wherein at least one hollow dacron visualization tube is disposed at a designated location of the main body structure; preferably, the two hollow terylene development tubes are symmetrically distributed on the edges of two sides of the main body structure.
9. The posterior scleral reinforcement structure of claim 5, wherein the hollow dacron visualization tube is integrally woven with the body structure or affixed to the body structure by gluing, suturing with sutures.
10. The posterior scleral reinforcement structure of any one of claims 1-9, wherein the imaging agent is water, sodium hyaluronate, gadolinium based imaging agents, or other material that is visibly distinguishable from the wall of the eyeball, the intraorbital fatty tissue in the nuclear magnetic resonance T2 phase.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN117563049A (en) * | 2024-01-15 | 2024-02-20 | 北京佰仁医疗科技股份有限公司 | Ophthalmic biological patch for posterior scleral reinforcement and preparation thereof |
| CN117563049B (en) * | 2024-01-15 | 2024-05-03 | 北京佰仁医疗科技股份有限公司 | Ophthalmic biological patch for posterior scleral reinforcement and preparation thereof |
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| US6378526B1 (en) * | 1998-08-03 | 2002-04-30 | Insite Vision, Incorporated | Methods of ophthalmic administration |
| CN102525729A (en) * | 2012-02-02 | 2012-07-04 | 温州医学院附属眼视光医院 | Biomembrane material strip belt for high-myopia posterior scleral reinforcement surgery and manufacture method thereof |
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| US6378526B1 (en) * | 1998-08-03 | 2002-04-30 | Insite Vision, Incorporated | Methods of ophthalmic administration |
| CN102525729A (en) * | 2012-02-02 | 2012-07-04 | 温州医学院附属眼视光医院 | Biomembrane material strip belt for high-myopia posterior scleral reinforcement surgery and manufacture method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN117563049A (en) * | 2024-01-15 | 2024-02-20 | 北京佰仁医疗科技股份有限公司 | Ophthalmic biological patch for posterior scleral reinforcement and preparation thereof |
| CN117563049B (en) * | 2024-01-15 | 2024-05-03 | 北京佰仁医疗科技股份有限公司 | Ophthalmic biological patch for posterior scleral reinforcement and preparation thereof |
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