CN108066054B - Scleral compression device for scleral reinforcement - Google Patents
Scleral compression device for scleral reinforcement Download PDFInfo
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- CN108066054B CN108066054B CN201611014106.2A CN201611014106A CN108066054B CN 108066054 B CN108066054 B CN 108066054B CN 201611014106 A CN201611014106 A CN 201611014106A CN 108066054 B CN108066054 B CN 108066054B
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- compression device
- sclera
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- 230000002787 reinforcement Effects 0.000 title claims abstract description 26
- 230000006835 compression Effects 0.000 title claims description 81
- 238000007906 compression Methods 0.000 title claims description 81
- 210000003786 sclera Anatomy 0.000 claims abstract description 76
- 238000003825 pressing Methods 0.000 claims abstract description 56
- 238000000034 method Methods 0.000 claims abstract description 25
- 239000011247 coating layer Substances 0.000 claims description 19
- 229910001285 shape-memory alloy Inorganic materials 0.000 claims description 14
- 239000012567 medical material Substances 0.000 claims description 12
- 239000011248 coating agent Substances 0.000 claims description 11
- 238000000576 coating method Methods 0.000 claims description 11
- 239000013307 optical fiber Substances 0.000 claims description 10
- 239000002861 polymer material Substances 0.000 claims description 10
- 210000001508 eye Anatomy 0.000 claims description 6
- 229910001069 Ti alloy Inorganic materials 0.000 claims description 5
- 230000036760 body temperature Effects 0.000 claims description 5
- 238000010146 3D printing Methods 0.000 claims description 3
- 238000002591 computed tomography Methods 0.000 claims description 3
- 238000002595 magnetic resonance imaging Methods 0.000 claims description 3
- 239000011347 resin Substances 0.000 claims description 3
- 229920005989 resin Polymers 0.000 claims description 3
- 238000005516 engineering process Methods 0.000 claims description 2
- 230000000694 effects Effects 0.000 abstract description 19
- 238000011282 treatment Methods 0.000 abstract description 9
- 238000011866 long-term treatment Methods 0.000 abstract description 7
- 239000000463 material Substances 0.000 description 12
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 8
- 239000000741 silica gel Substances 0.000 description 8
- 229910002027 silica gel Inorganic materials 0.000 description 8
- 230000004424 eye movement Effects 0.000 description 6
- 239000002131 composite material Substances 0.000 description 5
- 239000000835 fiber Substances 0.000 description 5
- 238000004519 manufacturing process Methods 0.000 description 5
- 230000004379 myopia Effects 0.000 description 4
- 208000001491 myopia Diseases 0.000 description 4
- 210000001328 optic nerve Anatomy 0.000 description 4
- 210000000795 conjunctiva Anatomy 0.000 description 3
- 238000010586 diagram Methods 0.000 description 3
- 210000003205 muscle Anatomy 0.000 description 3
- 208000002367 Retinal Perforations Diseases 0.000 description 2
- 230000005540 biological transmission Effects 0.000 description 2
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- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 238000009826 distribution Methods 0.000 description 2
- 238000005286 illumination Methods 0.000 description 2
- 239000010410 layer Substances 0.000 description 2
- 239000012779 reinforcing material Substances 0.000 description 2
- 230000000007 visual effect Effects 0.000 description 2
- 208000012260 Accidental injury Diseases 0.000 description 1
- 206010003694 Atrophy Diseases 0.000 description 1
- 201000004569 Blindness Diseases 0.000 description 1
- 239000004484 Briquette Substances 0.000 description 1
- 206010038848 Retinal detachment Diseases 0.000 description 1
- 235000009754 Vitis X bourquina Nutrition 0.000 description 1
- 235000012333 Vitis X labruscana Nutrition 0.000 description 1
- 240000006365 Vitis vinifera Species 0.000 description 1
- 235000014787 Vitis vinifera Nutrition 0.000 description 1
- 230000037444 atrophy Effects 0.000 description 1
- 239000012620 biological material Substances 0.000 description 1
- 210000005252 bulbus oculi Anatomy 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 230000006735 deficit Effects 0.000 description 1
- 230000004438 eyesight Effects 0.000 description 1
- 239000007888 film coating Substances 0.000 description 1
- 238000009501 film coating Methods 0.000 description 1
- 230000004402 high myopia Effects 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 238000002955 isolation Methods 0.000 description 1
- 208000029233 macular holes Diseases 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 230000003014 reinforcing effect Effects 0.000 description 1
- 230000004264 retinal detachment Effects 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 230000008961 swelling Effects 0.000 description 1
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Classifications
-
- 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
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/007—Methods or devices for eye surgery
-
- 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
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
- A61F9/0017—Introducing ophthalmic products into the ocular cavity or retaining products therein implantable in, or in contact with, the eye, e.g. ocular inserts
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B33—ADDITIVE MANUFACTURING TECHNOLOGY
- B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
- B33Y80/00—Products made by additive manufacturing
-
- 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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
-
- 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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0008—Fixation appliances for connecting prostheses to the body
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Ophthalmology & Optometry (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Surgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical & Material Sciences (AREA)
- Manufacturing & Machinery (AREA)
- Materials Engineering (AREA)
- Materials For Medical Uses (AREA)
Abstract
The sclera pressing device for sclera reinforcement comprises a pressing sheet and a pressing sheet fixing device, wherein the pressing sheet fixing device is of a thin-wall shell structure or a thin-wall net structure. The tabletting fixing device is provided with a positioning end through which the tabletting fixing device can be sutured and fixed on the sclera. The thin-wall shell structure or the thin-wall net structure of the tablet fixing device can apply pressure which is uniformly distributed and points to the part needing to be reinforced and pressed to the tablet, and simultaneously well prevent the tablet from deforming in the treatment process and shifting in the long-term treatment process, and better ensure the treatment effect of the operation, in particular the long-term treatment effect.
Description
Technical Field
The present invention relates to a surgical instrument for scleral reinforcement, and more particularly, to a scleral compression device for use in scleral reinforcement.
Background
Due to the wide application of various video tools, myopic people are also growing. In people over 5 years old in China, 1 person is myopia, the proportion of myopia in the general population over 5 years old is 35.16-39.21%, the total number of diseases of myopia is 4.37-4.87 hundred million, and the general population with high myopia is 2900-3040 ten thousand. The obvious change in ocular structure caused by myopia is the increase in the anterior-posterior diameter (axis) of the eyeball. This structural change in ocular axis growth causes a variety of complications in highly myopic patients, such as retinal holes, detachment, choroidal atrophy, severe impairment of vision, blindness, etc.
The use of biological materials to strengthen the posterior sclera of the eye (known as posterior scleral reinforcement) to make the axis less likely to continue to grow, (or slow down) is considered the only viable method of controlling the length of the highly myopic axis. The material, design, and surgical approach of the scleral reinforcement material all affect the surgical effect of the scleral reinforcement procedure. In particular, there are individual differences in the actual condition of each patient, such as: each patient's eye axis is different; posterior scleral grape swelling is different in height; if other diseases are associated, such as retinal detachment, macular holes, the size and the height of the roof pressure of the reinforcement required by the surgeon may also vary. The sclera reinforcement materials commonly used at present, including the macular buckles with various designs, are of fixed shapes and fixed models, and cannot be reinforced and jacked by selecting the most suitable reinforcement materials according to the actual conditions of each patient. In addition, the existing fixing mode is that the surgical thread is partially sutured and fixed, so that local stress concentration at the sutured position is easily caused, serious tearing even occurs at the sutured position, and the poor consequence of falling of the reinforcing material is caused, and therefore, the existing sclera reinforcing material needs to be improved.
Disclosure of Invention
The invention relates to a scleral compression device for scleral reinforcement, which is characterized in that: the scleral compression device 99 comprises a compression sheet 1 and a compression sheet fixing device 2;
A. the tabletting 1 is made of medical materials and can be attached to the sclera;
B. the tablet fixing device 2 is provided with a fixed end 21; the tablet fixing device 2 can be fixed on the sclera through the fixing end 21;
C. the tablet 1 can be attached and fixed on the sclera by the tablet fixing device 2.
When in clinical use, the pressing sheet 1 is attached to the position of the sclera 3, which is required to be reinforced and pressed, the pressing sheet fixing device 2 is fixed on the sclera 3 by the fixing end 21 of the pressing sheet fixing device 2, and then the pressing sheet 1 can be attached and fixed on the sclera 3, so that the use process is simple and convenient.
Further, the compression sheet 1 has a shape matching the sclera. Since the compression sheet 1 has a shape matching with the sclera 3, the compression sheet 1 can be well attached to the sclera 3 in clinical use, and the reinforcement and the pressing action of the compression sheet 1 on the sclera 3 can be better exerted.
The compression sheet 1 is manufactured according to three-dimensional data of CT scanning or MRI scanning of eyes or three-dimensional data provided by a 3D camera. Because the tablet 1 is manufactured according to three-dimensional data of a patient, good matching between the tablet 1 and a part needing reinforcement and jacking can be fully ensured, positioning is more accurate, and reinforcement and jacking effects are more obvious.
The tablet 1 is manufactured using 3D printing techniques.
The tablet 1 is manufactured by using a resin stamping technology.
The applicant has exemplified only the above 2 modes of manufacturing the tablet 1, but a person skilled in the art can select other various manufacturing techniques as needed without departing from the scope of the present patent application.
The tablet 1 contains an orientation pressing block 11. The directional pressing block 11 can be projected unidirectionally in a direction set in design, when the device is used, the directional pressing block 11 is aligned to a position on the sclera 3 needing to be reinforced and pressed, then the pressing block 1 is completely attached to the sclera 3 to be fixed, and the directional pressing block 11 directly acts on the position needing to be reinforced and pressed, so that the clinical use effect is better.
The tablet 1 is provided with a fiber conduit channel 12. The optical fiber 4 can be placed in the optical fiber catheter channel 12, and the reinforced and pressed part of the pressing sheet 1 can be directly observed in the operation process through the illumination effect of the optical fiber 4, so that the operation process is more visual, convenient and safe.
The tablet 1 comprises a support 13 and a coating 14.
The supporting body 13 is made of medical polymer materials, medical titanium alloy, medical shape memory alloy and the like; the coating layer 14 is made of a soft medical polymer material.
The tablet 1 may be made of a composite of a plurality of materials, and the support 13 may be made of a medical material having high strength, and then the surface may be coated with a soft coating layer to form the coating layer 14. Since the support 13 has a certain strength, the compression sheet 1 can be bent and shaped according to the shape of the sclera 3, and the compression sheet 1 can be fixed in a single-arm suspension manner. The soft coating 14 can be comfortably attached to the sclera 3, ensuring a good attachment between the compression sheet 1 and the sclera 3.
The compression fixation device 2 is a thin-walled housing structure or a thin-walled mesh structure 22.
Further, the thin-walled mesh structure 22 comprises a flexible mesh 22-1 that can be gathered and expanded.
The thin-walled mesh structure 22 also includes an edge 22-2, the edge 22-2 being located at the periphery of the flexible mesh 22-1. The height of the edge 22-2 is larger than the thickness of the edge of the tablet 1, so that the tablet 1 is ensured to be coated in the flexible net 22-1, and the tablet 1 is effectively prevented from shifting in the eye movement process. The edge 22-2 has higher strength than the fixing band 25 of the tablet fixing device 2, the meshed area formed by surrounding the edge 22-2 becomes a difficult deformation area, the fixing band 25 forms a deformable area, when the tablet fixing device 2 is acted by external force, the fixing band 25 deforms, the edge 22-2 does not deform, therefore, the tablet 1 fixed in the flexible net 22-1 does not extend and deform, the tablet 1 can stably press against the sclera 3 according to the designed shape and pressure distribution in the treatment process, and the accurate positioning and treatment of the sclera 3 are ensured.
In order to prevent the compression sheet 1 of the sclera compression device 99 from being stretched and deformed to affect the compression effect due to the stretching effect of the suture after the suture and fixation, and further prevent the suture from being torn due to local stress concentration at the fixation position of the sclera compression device 99, the compression sheet fixing device 2 generally adopts a thin-wall structure, such as a thin-wall shell structure or a thin-wall net structure 22, which can entirely cover the compression sheet 1, so as to ensure that the force applied by the compression sheet 1 after fixation is uniformly distributed and directed to the pressure of the part to be reinforced and pressed. Especially when the thin-wall net structure 22 is adopted, not only the uniformly distributed jacking force can be applied, but also the friction force between the tablet fixing device 2 and the tablet 1 can be increased, the tablet 1 is better fixed, the tablet 1 is well prevented from shifting during eye movement, and a good long-term treatment effect is ensured.
The fixed end 21 is provided with a positioning hole 21-1, and the tabletting fixing device 2 can be fixed on the sclera through the positioning hole 21-1. In the operation process, the operation wire 5 can pass through the positioning hole 21-1 to suture and fix the tabletting fixing device 2 on the sclera 3, so that on one hand, no surgical instrument is required to be additionally used for puncturing the tabletting fixing device 2 in the operation process, the use is more convenient, and on the other hand, as the hole edge of the positioning hole 21-1 is smooth, the operation wire 5 is fixed without sharp gaps, so that local stress concentration is less likely to be caused, and the tabletting fixing device 2 is effectively prevented from being torn by the operation wire 5 after being sutured.
The tablet fixing device 2 is made of medical materials; the medical material is selected from medical PE, medical TPU, medical silica gel, medical shape memory alloy, medical titanium alloy and the like.
The tablet holding device 2 comprises an inner liner 23 and a coating layer 24.
Further, the inner liner 23 is made of medical polymer material, medical titanium alloy, medical shape memory alloy, or the like; the coating 24 is made of a soft medical polymer material.
The tabletting fixing device 2 can be made of soft medical polymer materials such as medical silica gel and is convenient to suture. Or can be made of various medical materials. After the inner liner 23 is made of a medical material with high strength, a soft coating layer is covered on the surface to form the coating layer 24. Since the inner liner 23 has a certain strength, the compression sheet 1 can be better fixed and pressurized, and meanwhile, the compression sheet fixing device 2 can be bent and shaped, so that the compression sheet fixing device 2 is cantilever-fixed. Especially, when the inner liner 23 is made of a medical shape memory alloy, the tablet fixing device 2 can be made into a shape which is very small in size and easy to put in, and after entering a human body, the shape memory property of the shape memory alloy is utilized under the action of body temperature, and then the required shape is recovered, so that the clinical operation is convenient. The soft coating 24 is fully adhered to the wafer 1, well allowing for even force transmission and facilitating fixation of the wafer fixation device 2 to the sclera 3.
The tablet 1 is non-detachably connected to the tablet holder 2. The tablet 1 and the tablet fixing device 2 can be integrally manufactured, or the tablet 1 can be connected with the tablet fixing device 2 through bonding, welding and the like, so that the tablet is convenient to put into clinical use.
The tablet 1 is detachably connected to the tablet holder 2. The pressing sheet 1 and the pressing sheet fixing device 2 are separated, and the pressing sheet 1 is embedded in the pressing sheet fixing device 2 in a concave-convex clamping fit mode.
Further, the tablet holder 2 has a shape matching the tablet 1; the pressing sheet 1 is arranged on the inner side of the pressing sheet fixing device 2, and the pressing sheet 1 can be attached and fixed on the sclera 3 through the pressing sheet fixing device 2.
In clinical use, the tabletting 1 is first inlaid in a thin-wall shell structure or a thin-wall net structure of the tabletting fixing device 2, the bulbar conjunctiva is cut along the limbus in clinical operation, the external, upper and lower rectus muscles are lifted, the sclera pressing device 99 is placed to the position where the sclera 3 needs to be reinforced and pressed, then the fixing band 25 is placed at the position where the fixing band needs to be fixed, and the fixing device 2 is sutured and fixed on the sclera 3 by using the surgical wire 5 through the positioning hole 21-1 of the tabletting fixing device 2. The flexible net 22-1 of the tablet fixing device 2 can cover the tablet 1, effectively prevent the tablet 1 from shifting due to eye movement, provide uniformly distributed pressure to the tablet 1 and point to the part needing reinforcement and jacking, and ensure continuous and effective reinforcement and jacking of the tablet 1 to the sclera 3.
The scleral compression device for scleral reinforcement of the present invention comprises the compression sheet 1 and the compression sheet fixing device 2, wherein the compression sheet fixing device 2 is a thin-walled shell structure or a thin-walled net structure. The positioning end 21 is provided on the tablet fixing device 2, and the tablet fixing device 2 can be sutured and fixed on the sclera 3 through the positioning end 21. The thin-wall shell structure or the thin-wall net structure of the tablet fixing device 2 can apply pressure which is uniformly distributed and points to the part needing to be reinforced and pressed to the tablet 1, and simultaneously well prevent the tablet 1 from deforming in the treatment process and shifting in the long-term treatment process, and better ensure the treatment effect of the operation, in particular the long-term treatment effect.
Drawings
FIG. 1 is a schematic view of a scleral compression device for scleral stiffening according to the present invention shown in isolation.
Fig. 1-1 is a cross-sectional view A-A of fig. 1.
Fig. 2 is a schematic view of the structure of the tablet when the tablet is fitted on the tablet holder.
Fig. 2-1 is a B-B cross-sectional view of fig. 2.
Fig. 3 is a schematic structural view of a tablet comprising directional compacts.
Fig. 3-1 is a C-C cross-sectional view of fig. 3.
Fig. 4 is a schematic structural view of a preform containing a fiber optic conduit channel.
Fig. 4-1 is a D-D cross-sectional view of fig. 4.
Fig. 5 is a schematic diagram of the operation of the scleral compression device for scleral stiffening in accordance with the present invention.
Fig. 6 is an exploded view of a scleral compression device for scleral stiffening in accordance with the present invention with an orientation compact.
Fig. 7 is a schematic diagram of the operation of a scleral compression device for scleral stiffening of the present invention including an optical fiber.
Fig. 8 is a schematic view of a construction of a scleral compression device for scleral stiffening in accordance with the present invention integrally manufactured.
Fig. 8-1 is a sectional view of E-E of fig. 8.
Fig. 9 is a schematic diagram of the operation of the integrally manufactured scleral compression device for scleral stiffening of the present invention.
In the above figures:
1 is a tabletting, 2 is a tabletting fixing device, 3 is a sclera, 4 is an optical fiber, 5 is an operation wire, 6 is an optic nerve, and 99 is a sclera pressurizing device of the present invention.
11 is a directional pressing block, 12 is an optical fiber conduit channel, 13 is a support body of the pressing sheet, and 14 is a coating layer of the pressing sheet.
21 is a positioning end, and 21-1 is a positioning hole; 22 is a thin-wall net structure, 22-1 is a flexible net, and 22-2 is an edge; 23 is the lining of the tablet fixing device, 24 is the film coating layer of the tablet fixing device, and 25 is the fixing belt.
Description of the embodiments
Example 1: the scleral compression device for scleral reinforcement of the present invention
Referring to fig. 1 to 2-1, in this embodiment, the scleral compression device 99 includes a compression plate 1 and a compression plate fixing device 2. The tablet 1 and the tablet holder 2 are detachably connected together, and the tablet 1 is embedded in a flexible net 22-1 of the tablet holder 2, see fig. 2 and 2-1.
The compression sheet 1 is made of medical material and can be attached to the sclera 3. In this embodiment, the compression sheet 1 is made of a medical silica gel material, and the soft medical silica gel material has good elasticity, so that soft pressure can be applied to the sclera 3, and the use comfort of a patient is enhanced.
The tablet fixing device 2 is provided with a fixed end 21; the compression fixing device 2 is fixable to the sclera by the fixing end 21.
The tablet 1 can be attached and fixed on the sclera by the tablet fixing device 2.
Further, the compression sheet 1 has a shape matching the sclera. Since the compression sheet 1 has a shape matching with the sclera 3, the compression sheet 1 can be well attached to the sclera 3 in clinical use, and the reinforcement and the pressing action of the compression sheet 1 on the sclera 3 can be better exerted.
The compression sheet 1 is manufactured according to three-dimensional data of CT scanning or MRI scanning of eyes or three-dimensional data provided by 3D camera scanning. Of course, those skilled in the art may select other technical means capable of providing three-dimensional data of the eye to collect the relevant three-dimensional data without departing from the scope of the present application. Because the tablet 1 is manufactured according to three-dimensional data of a patient, good matching between the tablet 1 and a part needing reinforcement and jacking can be fully ensured, positioning is more accurate, and reinforcement and jacking effects are more obvious.
In this embodiment, the preform 1 is manufactured using 3D printing techniques.
Of course, the tablet 1 may be manufactured by other techniques such as resin molding, without departing from the scope of the present application.
In this embodiment, the tablet holder 2 is a thin-walled mesh structure 22.
The thin-walled mesh structure 22 comprises a flexible mesh 22-1 that can be gathered and expanded.
The thin-wall net structure 22 not only can ensure that the pressing sheet 1 is uniformly distributed and points to the position to be reinforced and pressed after being fixed, but also can prevent the pressing sheet 1 of the sclera pressing device 99 from being stretched and deformed to influence the pressing effect due to the stretching effect of the suture position after being sutured and fixed, and further can prevent the suture position of the fixed position of the sclera pressing device 99 from being torn due to local stress concentration to cause operation failure; moreover, the friction force between the tablet fixing device 2 and the tablet 1 can be increased, the tablet 1 is better fixed, the tablet 1 is well prevented from shifting during eye movement, and good long-term treatment effect is ensured.
In this embodiment, the thin-walled mesh structure 22 includes an edge 22-2, the edge 22-2 being located at the periphery of the flexible mesh 22-1. The height of the edge 22-2 is larger than the thickness of the edge of the tablet 1, so that the tablet 1 is ensured to be coated in the flexible net 22-1, and the tablet 1 is effectively prevented from shifting during the eye movement, and the tablet is shown in fig. 2 and 2-1. The edge 22-2 has higher strength than the fixing band 25 of the tablet fixing device 2, the meshed area formed by surrounding the edge 22-2 becomes a difficult deformation area, the fixing band 25 forms a deformable area, when the tablet fixing device 2 is acted by external force, the fixing band 25 deforms, the edge 22-2 does not deform, therefore, the tablet 1 fixed in the flexible net 22-1 does not extend and deform, the tablet 1 can stably press against the sclera 3 according to the designed shape and pressure distribution in the treatment process, and the accurate positioning and treatment of the sclera 3 are ensured.
The tablet fixing device 2 may also be a thin-wall shell structure, or any other thin-wall structure capable of covering the tablet 1, without departing from the protection scope of the present application. The fixing of the tablet 1 in the tablet holder 2 is achieved in any other way and does not depart from the scope of the present application.
The fixed end 21 is provided with a positioning hole 21-1, and the tabletting fixing device 2 can be fixed on the sclera through the positioning hole 21-1. In the operation process, the operation wire 5 can pass through the positioning hole 21-1 to suture and fix the tabletting fixing device 2 on the sclera 3, so that on one hand, no surgical instrument is required to be additionally used for puncturing the tabletting fixing device 2 in the operation process, the use is more convenient, and on the other hand, as the hole edge of the positioning hole 21-1 is smooth, the operation wire 5 is fixed without sharp gaps, so that local stress concentration is less likely to be caused, and the tabletting fixing device 2 is effectively prevented from being torn by the operation wire 5 after being sutured.
In this embodiment, the tablet fixing device 2 is made of medical elastic silica gel material, and the soft medical silica gel material has good elasticity, so that on one hand, the tablet fixing device can be conveniently fixed, and on the other hand, the pressure applied to the tablet 1 is softer, and the comfort of a patient is better.
The tablet fixing device 2 can also be made of various medical materials in a composite mode. The tablet holding device 2 is made as a composite structure comprising an inner liner 23 and a coating 24. The inner liner 23 is made of medical polymer material, medical titanium alloy, medical shape memory alloy, etc.; the coating 24 is made of a soft medical polymer material. After the inner liner 23 is made of a medical material with high strength, a soft coating layer is covered on the surface to form the coating layer 24. Since the inner liner 23 has a certain strength, the compression sheet 1 can be better fixed and pressurized, and meanwhile, the compression sheet fixing device 2 can be bent and shaped, so that the compression sheet fixing device 2 is cantilever-fixed. Especially, when the inner liner 23 is made of a medical shape memory alloy, the tablet fixing device 2 can be made into a shape which is very small in size and easy to put in, and after entering a human body, the shape memory property of the shape memory alloy is utilized under the action of body temperature, and then the required shape is recovered, so that the clinical operation is convenient. The soft coating 24 is fully adhered to the wafer 1, well allowing for even force transmission and facilitating fixation of the wafer fixation device 2 to the sclera 3.
In clinical use, the tabletting 1 is first inlaid in the thin-wall shell structure or the thin-wall net structure 22 of the tabletting fixing device 2, during clinical operation, the bulbar conjunctiva is cut along the limbus, the external, upper and lower rectus muscles are lifted, the sclera pressing device 99 is placed to the position where the sclera 3 needs to be reinforced and pressed, then the fixing band 25 is placed at the position where the fixing band needs to be fixed after the optic nerve 6 is avoided, and the fixing device 2 is sutured and fixed on the sclera 3 by using the operation wire 5 through the positioning hole 21-1 of the tabletting fixing device 2. The flexible net 22-1 of the tablet fixing device 2 can cover the tablet 1, effectively prevent the tablet 1 from shifting due to eye movement, provide pressure which is uniformly distributed to the tablet 1 and points to the part needing reinforcement and pressing, and ensure continuous and effective reinforcement and pressing of the tablet 1 to the sclera 3, refer to fig. 5.
The sclera pressurizing device for sclera reinforcement of the present invention is used for reinforcing the sclera 3, and has good clinical treatment effect, especially good long-term treatment effect.
Example 2: scleral compression device for scleral stiffening of the present invention including directional compacts
Referring to fig. 3 to 3-1, this embodiment is different from embodiment 1 in that in this embodiment, the tablet 1 further includes a directional briquette 11.
The directional pressing block 11 is arranged on the inner side of the pressing sheet 1 and can be unidirectionally protruded in the direction of pressing. The directional pressing block 11 can be individually designed according to three-dimensional clinical data of a patient, so that good fit of the part of the sclera 3 to be reinforced is ensured. When in use, the directional pressing block 11 is aligned to the position on the sclera 3 to be reinforced and pressed, the pressing sheet 1 is completely attached to the sclera 3, the pressing sheet fixing device 2 is covered on the outer side of the pressing sheet 1, and the fixing device 2 is sewed and fixed on the sclera 3 by the operation wire 5 through the positioning hole 21-1 of the pressing sheet fixing device 2, referring to fig. 6.
In this embodiment, the directional pressing block 11 directly acts on the position to be reinforced and pressed, so that the clinical use effect is better.
Furthermore, a fiber guide channel 12 may be provided in the preform 1, and referring to fig. 4 and 4-1, the fiber 4 may be placed in the fiber guide channel 12. When in clinical use, the optical fiber 4 is inserted into the optical fiber catheter channel 12, the light source is connected, the reinforced and jacking position of the pressing sheet 1 can be directly observed in the operation process under the illumination action of the optical fiber 4, and the operation process is more visual, convenient and safe, and the figure 7 is referred to.
The tablet 1 can also be made of various materials in a composite way, and the tablet is made into a composite structure comprising a support body 13 and a coating layer 14. In the manufacturing process, the supporting body 13 is made of medical materials with high strength, and then a soft coating layer is coated on the surface to form the coating layer 14. Since the support 13 has a certain strength, the compression sheet 1 can be bent and shaped according to the shape of the sclera 3. The soft coating 14 can be comfortably attached to the sclera 3, ensuring a good attachment between the compression sheet 1 and the sclera 3, see fig. 8-9.
Of course, those skilled in the art can devise various other tabletting structures without departing from the scope of the present application.
Example 3: integrally manufactured scleral compression device for scleral stiffening in accordance with the present invention
Referring to fig. 8 and 8-1, this embodiment differs from embodiment 1 and embodiment 2 in that in this embodiment, the tablet 1 and the tablet holder 2 are integrally manufactured.
The scleral compression device 99 includes a cast 1 and a cast fixation device 2, the cast 1 and the cast 2 being formed by a monolithic manufacturing technique.
The tablet 1 comprises a support 13 and a coating 14.
The support 13 is made of medical shape memory alloy, and the coating layer 14 is made of soft silica gel material.
The tablet holding device 2 comprises an inner liner 23 and a coating layer 24. The inner liner 23 is made of medical shape memory alloy, and the coating layer 24 is made of soft silica gel material. The film layer 24 at the end part of the tablet fixing device 2 is provided with a positioning hole 21-1. In shape memory design, the scleral compression device 99 is designed to contract at low temperatures and expand at body temperature.
In clinical use, the bulbar conjunctiva is cut along the limbus, the external, upper and lower rectus muscles are lifted, the sclera pressing device 99 which is processed and contracted at low temperature is placed to the position where the sclera 3 needs to be reinforced and pressed, the sclera pressing device 99 is unfolded under the action of body temperature, the tabletting 1 reinforces and presses the sclera 3, and then the sclera pressing device 99 is sutured and fixed on the sclera after the surgical wire 5 passes through the positioning hole 21-1, referring to fig. 9. During surgery, care should be taken to avoid the optic nerve 6 to prevent accidental injury to the optic nerve after deployment of the scleral compression device 99.
In this embodiment, the compression sheet 1 and the compression sheet fixing device 2 are manufactured by using the memory property of the shape memory alloy and adopting an integral manufacturing process, and the operation process is simpler and more convenient.
It should be noted that the structures disclosed and described herein may be replaced by other structures having the same effect, and that the embodiments described herein are not the only structures for implementing the present invention. Although preferred embodiments of the present invention have been described and illustrated herein, it will be apparent to those skilled in the art that these embodiments have been presented by way of example only, and that numerous changes, modifications and substitutions can be made herein by one skilled in the art without departing from the invention, and therefore the scope of the invention is to be defined by the spirit and scope of the appended claims.
Claims (18)
1. Scleral compression device for scleral reinforcement, characterized in that: the scleral compression device (99) includes: a tabletting (1) and a tabletting fixture (2) made of medical materials and used for being attached on the sclera;
A. the tabletting fixing device (2) is provided with a fixed end (21) for fixing on a sclera;
B. the tabletting fixing device (2) enables the tabletting (1) to be attached and fixed on the sclera;
C. the tabletting fixing device (2) comprises a lining (23) and a coating layer (24); the lining (23) is a part made of medical shape memory alloy, the tablet fixing device (2) is made into a shape which is small in size and easy to put in, and after entering a human body, the shape memory characteristic of the shape memory alloy is utilized to recover the required shape under the action of body temperature, so that the tablet fixing device is convenient for clinical operation.
2. A scleral compression device for scleral stiffening according to claim 1, characterized in that: the compression sheet (1) has a shape matching with the sclera.
3. A scleral compression device for scleral stiffening according to claim 2, characterized in that: the compression sheet (1) is a component manufactured according to three-dimensional data of CT scanning or MRI scanning of eyes or three-dimensional data provided by a 3D camera.
4. A scleral compression device for scleral stiffening according to claim 3, characterized in that: the preform (1) is a component manufactured using 3D printing techniques.
5. A scleral compression device for scleral stiffening according to claim 3, characterized in that: the tablet (1) is a component manufactured by a resin stamping technology.
6. A scleral compression device for scleral stiffening according to claim 1, characterized in that: the tabletting (1) comprises a directional pressing block (11).
7. A scleral compression device for scleral stiffening according to claim 1, characterized in that: the tablet (1) is provided with an optical fiber conduit channel (12).
8. A scleral compression device for scleral stiffening according to claim 1, characterized in that: the tablet (1) comprises a support (13) and a coating layer (14).
9. The scleral compression device for scleral stiffening of claim 8, wherein: the supporting body (13) is a supporting component made of medical polymer materials, medical titanium alloy or medical shape memory alloy; the coating layer (14) is a coating film component made of soft medical polymer materials.
10. A scleral compression device for scleral stiffening according to claim 1, characterized in that: the pressing sheet fixing device (2) is of a thin-wall shell structure or a thin-wall net structure (22).
11. The scleral compression device for scleral stiffening of claim 10, wherein: the thin-walled mesh structure (22) comprises a flexible mesh (22-1) that can be gathered and expanded.
12. The scleral compression device for scleral stiffening of claim 11, wherein: the thin-walled mesh structure (22) further comprises an edge (22-2), the edge (22-2) being located at the periphery of the flexible mesh (22-1).
13. A scleral compression device for scleral stiffening according to claim 1, characterized in that: the fixed end (21) is provided with a positioning hole (21-1).
14. A scleral compression device for scleral stiffening according to claim 1, characterized in that: the tablet fixing device (2) is a part made of medical materials.
15. A scleral compression device for scleral stiffening according to claim 1, characterized in that: the coating layer (24) is a coating component made of soft medical polymer materials.
16. A scleral compression device for scleral stiffening according to claim 1, characterized in that: the pressing piece (1) is undetachably connected to the pressing piece fixing device (2).
17. A scleral compression device for scleral stiffening according to claim 1, characterized in that: the pressing piece (1) is detachably connected to the pressing piece fixing device (2).
18. A scleral compression device for scleral stiffening according to claim 17, characterized in that: the tablet fixing device (2) is provided with a shape matched with the tablet (1); the tabletting (1) is arranged on the inner side of the tabletting fixing device (2), and the tabletting (1) can be attached and fixed on the sclera through the tabletting fixing device (2).
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| CN201611014106.2A CN108066054B (en) | 2016-11-17 | 2016-11-17 | Scleral compression device for scleral reinforcement |
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| CN110302005B (en) * | 2019-07-16 | 2024-06-14 | 上海交通大学医学院附属第九人民医院 | Posterior sclera quantitative pressurizing block and application method thereof |
| JP2023518975A (en) * | 2020-03-23 | 2023-05-09 | オプティゴン エルエルシー | Macular depressor and method of use and manufacture thereof |
| CN112569044B (en) * | 2020-12-10 | 2022-09-09 | 北京大学第三医院（北京大学第三临床医学院） | Posterior scleral staphyloma stent |
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| 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 |
| CN203943802U (en) * | 2014-06-27 | 2014-11-19 | 广州卫视博生物科技有限公司 | Rear sclera bracing means |
| DE102014221263A1 (en) * | 2014-10-20 | 2016-04-21 | Alamedics Gmbh & Co. Kg | Device for illuminating the intraocular space |
| CN206924144U (en) * | 2016-11-17 | 2018-01-26 | 广州迪克医疗器械有限公司 | The sclera pressue device reinforced for sclera |
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| 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 |
| CN203943802U (en) * | 2014-06-27 | 2014-11-19 | 广州卫视博生物科技有限公司 | Rear sclera bracing means |
| DE102014221263A1 (en) * | 2014-10-20 | 2016-04-21 | Alamedics Gmbh & Co. Kg | Device for illuminating the intraocular space |
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