CN111772871B

CN111772871B - Artificial vitreous body device suitable for children suffering from ocular, cerebral and renal syndromes

Info

Publication number: CN111772871B
Application number: CN202010535104.8A
Authority: CN
Inventors: 樊云葳; 李宁东; 李莉; 梁天蔚; 刘雯; 吴倩; 曹文红; 王媛
Original assignee: Beijing Childrens Hospital
Current assignee: Beijing Childrens Hospital
Priority date: 2020-06-12
Filing date: 2020-06-12
Publication date: 2024-09-24
Anticipated expiration: 2040-06-12
Also published as: CN111772871A

Abstract

The invention provides an artificial vitreous body device suitable for children suffering from the syndrome of the eyes, the brain and the kidney comprises: the silicone rubber membrane is provided with a port filled with silicone oil and an internally closed space connected with the port, and is in a membrane shape when being unfolded into a plane, and is in a sphere shape after being filled with silicone oil; a wire mesh cast within an inner wall of a silicone rubber membrane, the wire mesh comprising: a first metal wire arranged along the direction vertical to the eye axis and a second metal wire arranged along the direction vertical to the eye axis, wherein the first metal wire and the second metal wire are intersected into a grid shape; a valve disposed at a port of the silicone rubber membrane, the valve having a through-hole therethrough and a sidewall surrounding the through-hole; the through hole is communicated with the internal closed space, and the side wall surrounding the through hole is provided with an elastic sealing surface; and the auxiliary pipe is arranged in the valve in a translation way. The invention avoids the phenomenon of eyeball depression and the like of the artificial vitreous body.

Description

Artificial vitreous body device suitable for children suffering from ocular, cerebral and renal syndromes

Technical Field

The invention relates to the field of ophthalmic medical equipment, in particular to an artificial vitreous body device suitable for children suffering from ocular, cerebral and renal syndromes.

Background

Ocular brain kidney syndrome, also known as Lowe syndrome, is a rare sex-linked recessive genetic disorder. Clinically, congenital cataracts, low intelligence, and renal tubular acidosis are characterized, and birth defects exist, but symptoms are more pronounced in infancy or later. Ocular, brain, kidney changes can also occur at different ages, respectively.

Ocular symptoms of Lowe syndrome are: congenital bilateral cataracts, accompanied by congenital glaucoma; vitreous opacity, severe vision impairment, light sensation only or total blindness; coarse nystagmus, photophobia, and the like are common.

Lowe syndrome can be categorized into infancy, childhood and adulthood according to the course of the natural disease. In infancy, with various eye abnormalities and skull malformations as the obvious characteristics, eyes are common with congenital cataract and congenital glaucoma, eye shake, floating-like movement of eyeballs and blindness can be accompanied, and various skull malformations such as long clamping head, forehead Gao Tu, saddle nose, high palate arch and the like can appear in the diagnosis due to blindness, with serious intelligence decline, muscle tension decline, tendon reflex weakening or disappearance. It can be manifested by excessive excitation, shouting, general convulsion, etc. In this period, there is no abnormal kidney, but obvious rickets signs can appear.

According to analysis, the eye abnormalities, congenital cataract, vitreous opacity and the like of infants can cause serious obstruction to environmental perception, so that symptoms such as low intelligence and the like are aggravated. Among the overall treatment regimens, early treatment of ocular disorders is preferred.

In the treatment of eye diseases, cataract treatment is easy to pay attention, and the surgical treatment method is very mature, but the symptom of vitreous opacity is still not paid attention to. The first is because the degree of vitreous opacity during infancy is relatively weak relative to the effects of cataracts; secondly, the existing vitreous opacity treatment method still has more problems. However, after cataract surgery, the influence of vitreous opacity is remarkable.

The existing vitreous opacity treatment methods mainly comprise two methods:

(1) Silicone oil filling method. Because silicone oil has the characteristics of good light transmittance and small damage to human bodies, silicone oil substances are widely applied in the medical field. After vitreous opacity, the turbid gelatinous fluid is removed and replaced with silicone oil, and the method is suitable for retina damage-free conditions. The therapeutic effect is good in a short period of time, but the emulsification phenomenon of silicone oil is developed for a long period of time (after 6 months), and particularly acts on the crystalline lens to damage the crystalline lens. The longer the time, the more obvious the silicone oil emulsification phenomenon, and complications such as cornea zonal degeneration, cornea endothelial decompensation, secondary glaucoma and the like can be caused. After serious complications, only silicone oil can be selected and removed, and then the phenomenon of the atrophy of the eye ball can not be controlled until the eyeball is removed. Thus, the silicone oil filling method is a short-term treatment method for vitreous opacity.

(2) Artificial vitreous implantation. With the progress of the related technology, a silica gel capsule artificial vitreous body is gradually used at present, and the artificial vitreous body is replaced by the artificial vitreous body after being implanted into an eyeball. Taking a folding artificial vitreous body with good application effect at present as an example for explanation, the material is silicon rubber, and the folding artificial vitreous body consists of a balloon, a drainage tube and a drainage valve. The surgical method (see fig. 1a, 1b, 1c, 1d, 1e and 1 f) is to treat the vitreous body and the stock solution in the eyeball, implant the folded vitreous body balloon into the eye through the incision of 4mm on the surface of the eyeball, inject silicone oil into the balloon, expand the balloon until contacting with the retina, and play a role of filling the eye. The advantages are that: the silicone oil is coated by the saccule material, almost does not emulsify, and is isolated from the intraocular tissue by the saccule material, thereby avoiding the complication of the original silicone oil in the eye. The treatment method has been developed and popularized.

From the above analysis, the silicone oil filling method is simple, but the long-term application of the silicone oil filling method causes a plurality of complications. The artificial glass body implantation method well solves the problems and has good development prospect. However, the artificial vitreous body still needs to be customized by a single person in the operation method, so that the volume and shape of the filled silicone oil are slightly smaller than those of the actual vitreous body to prevent the vitreous body from causing larger pressure on the retina, and the supporting effect on the retina is poor; to adjust the pressure of the filling silicone oil, the drainage tube and valve are fixed outside the sclera, with potential abrasion effects.

Because most patients with the ocular brain kidney syndrome are infants, eyeballs are in a rapid development period, the appearance and the volume of the existing artificial vitreous body are difficult to adapt, the pressure of the filled silicone oil is required to be regulated, the patients with the ocular brain kidney syndrome are difficult to cooperate, whether the intraocular pressure is adaptive or not cannot be determined, and new damage is easily caused.

In summary, the following problems exist in the prior art: after the existing artificial vitreous body is implanted, the appearance and the volume are difficult to adapt to the development requirement of a patient, and the intraocular pressure cannot be adapted and adjusted.

Disclosure of Invention

The invention provides an artificial vitreous body device suitable for children suffering from ocular, cerebral and renal syndromes, which aims to solve the problems that after the existing artificial vitreous body is implanted, the appearance and the volume are difficult to adapt to the development requirement of a patient, and the intraocular pressure cannot be adapted to adjustment.

To this end, the present invention proposes an artificial vitreous apparatus suitable for infants suffering from ocular, cerebral and renal syndromes, comprising:

the silicone rubber membrane is provided with a port filled with silicone oil and an internally closed space connected with the port, and is in a membrane shape when being unfolded into a plane, and is in a sphere shape after being filled with silicone oil;

A wire mesh cast within an inner wall of a silicone rubber membrane, the wire mesh comprising: a first metal wire arranged along the direction vertical to the eye axis and a second metal wire arranged along the direction vertical to the eye axis, wherein the first metal wire and the second metal wire are intersected into a grid shape;

a valve disposed at a port of the silicone rubber membrane, the valve having a through-hole therethrough and a sidewall surrounding the through-hole; the through hole is communicated with the internal closed space, and the side wall surrounding the through hole is provided with an elastic sealing surface;

An auxiliary tube translatable within the valve, the auxiliary tube comprising: the sealing device comprises a tubular main body and a sealing end connected with the tubular main body, wherein the tubular main body is provided with a fluid filling port, a fluid channel and a channel outlet, the fluid filling port, the fluid channel and the channel outlet are communicated with each other, and the fluid channel and the channel outlet are disconnected from the sealing end; the sealing end is internally provided with an adjusting hole, the adjusting hole is provided with an inlet end and an outlet end, the inlet end is positioned at one end, close to the fluid filling port, in the sealing end, and the outlet end is positioned at one end, far away from the fluid filling port and extends to the outer surface of the sealing end.

Further, the outer edge of the sealing end is further provided with a cutting groove for cutting off the tubular main body, and the distance between the cutting groove and the fluid filling port is larger than that between the channel outlet and the fluid filling port.

Further, the wire mesh is distributed on the silicone rubber membrane in a region corresponding to the weak retina induction area.

Further, the sealing end includes: first sealing ball and second sealing ball, first sealing ball is spherical, and the second sealing ball is hemispherical, the second sealing ball is connected with tubular main part, sealed end still includes: the main body of the transition connecting section is cylindrical, the diameters of the first sealing ball and the second sealing ball are equal, the diameter of the transition connecting section is smaller than that of the first sealing ball or the second sealing ball,

Further, the inlet end is located in the second sealing ball, and the outlet end is located in the first sealing ball.

Further, the diameter of the tubular body is greater than the diameter of the narrowest of the through holes.

Further, the side wall surrounding the through hole is in an arch shape protruding towards the axis direction of the through hole.

Further, the fluid filling port is located in an axial direction of the tubular body, the channel outlet is located laterally of the tubular body, and the cutoff slot is located between the inlet end and the channel outlet.

Further, the first wire arranged in the direction perpendicular to the eye axis is annular, and the curve diameter of the annular is 25mm.

Further, the first metal wire or the second metal wire adopts metal wires with the thickness of 50 μm and the width of 100 μm, and the mesh size of the metal wire mesh is as follows: 1mm long and 1mm wide.

The invention has the following advantages:

1. The weak elastic design of the metal wire mesh enables the artificial vitreous body to have fine adjustment capability, can be closely contacted with retina, provides simulation support and is matched with the intraocular pressure not lower than 4KPa; the wire mesh can not be punctured and damaged, and the titanium alloy meets the medical related standard. The weak elastic support can prevent the phenomenon of eyeball sinking and the like in the conventional technology in the development process of the child patient;

2. Under the autonomous regulation of visual cells and optic nerves on retina, such as eyeball muscle and brain adaptability, the metal wire mesh with the spiral supporting structure has weakened shading effect and even no influence;

3. An artificial vitreous body suitable for children suffering from the eye-brain-kidney syndrome is designed. The valve is suitable for the change of the eyeball diameter of an infant from 1.5cm to 2.0cm, the intraocular pressure bearing range is +/-2 KPa, and the self-sealing valve avoids the abrasion phenomenon of the valve in the prior art.

Drawings

FIG. 1a is a schematic cross-sectional view of an eyeball structure;

FIG. 1b is a schematic structural view of a prior art artificial glass body;

FIG. 1c is a schematic illustration of the cleaning principle of an anterior ocular segment prior art artificial vitreous installation;

FIG. 1d is a schematic diagram of an artificial vitreous body of the prior art implanted into an eyeball;

FIG. 1e is a schematic diagram of an artificial vitreous body filled silicone oil of the prior art;

FIG. 1f is a schematic diagram of the principle of drainage tube and valve positioning after silicone oil is filled into the artificial vitreous body in the prior art;

FIG. 2 is a schematic illustration of the filling effect of the artificial vitreous body device of the present invention after filling with silicone oil;

FIG. 3a is a schematic view of hoop stress of a metal ring;

FIG. 3b is a dimensional parameter of a metal ring;

FIG. 4 is a schematic view showing the retinal area division of an eyeball;

FIG. 5 is a schematic representation of the distribution of visual cells on the retina;

FIG. 6 is a schematic view of a wire mesh of the present invention in a retinal position;

FIG. 7a is a schematic view showing a front view of the artificial vitreous device of the present invention in a curled state prior to surgical implantation;

FIG. 7b is a schematic side view of the artificial glass body device of FIG. 7 a;

FIG. 7c is a schematic view of the artificial vitreous device of the present invention in its deployed state prior to surgical implantation;

FIG. 8a is a schematic diagram of the operation of an anterior mold containing a retinal weak feel region for making a micro elastic membrane according to the present invention;

FIG. 8b is a schematic diagram of the operation of a posterior mold containing a retinal sensitive area for making the micro elastic membrane of the present invention;

FIG. 9a is an initial state of a conventional artificial vitreous body;

FIG. 9b is a view showing a state of a good fitting after the initial implantation of the artificial vitreous body in the prior art;

FIG. 9c is a graph showing the deformation trend of a conventional artificial vitreous body filled with silicone oil;

FIG. 9d is a schematic view showing the effect of the silicone oil filled into the conventional artificial vitreous body to cooperate with eyes;

FIG. 10a is a schematic side view of the valve of the present invention;

FIG. 10b is a schematic diagram of the front view of the valve of the present invention;

FIG. 11 is a schematic diagram of the front view of the auxiliary tube of the present invention;

FIG. 12a is a schematic view of the auxiliary tube of the present invention in a valve;

FIG. 12b is a schematic view of the auxiliary tube pull valve of the present invention;

FIG. 12c shows the sealing state of the valve after the auxiliary tube is sheared;

FIG. 13a is a schematic diagram of the cleaning operation of the artificial vitreous device of the present invention prior to implantation;

FIG. 13b is a schematic view of an artificial vitreous device of the present invention in an implanted state in an eye;

FIG. 13c is a schematic diagram of the silicone oil filling operation of the artificial vitreous body device of the present invention;

FIG. 13d is a schematic view of the structure of the artificial vitreous body device of the present invention after filling with silicone oil.

Reference numerals illustrate:

1. Silicone rubber film (micro elastic film); 2. a wire mesh; 3. a valve (inner seal valve); 4. an auxiliary tube; 5. a through hole;

21. a first wire; 22. a second wire; 31. a through hole; 33. a sidewall;

41. Sealing the end; 411. a first sealing ball; 412. a transition connection section; 413. a second sealing ball; 43. an adjustment hole; 431. An outlet end; 435. an inlet end; 45. cutting off the groove; 47. a fluid channel; 470. a fluid filling port; 475. a channel outlet; 49. a main body.

Detailed Description

For a clearer understanding of technical features, objects, and effects of the present invention, the present invention will be described with reference to the accompanying drawings.

As shown in fig. 2, 7a, 7b, and 7c, the artificial vitreous body device for children suffering from ocular brain kidney syndrome of the present invention comprises:

The silicon rubber film 1, also called micro elastic film, is in a film shape, the thickness of a simple film is 20 mu m, which exceeds the thickness of a conventional artificial vitreous body (10 mu m), the aim is to increase the pressure-resistant degree, ensure the diameter (1.5-2.2 cm) of the vitreous body to be increased in the later stage, and the service life limit is not less than 5 years. The silicone rubber membrane 1 is provided with a port filled with silicone oil and an internally closed space connected with the port, and is in a membrane shape when being unfolded into a plane, and is in a three-dimensional spherical shape or an apple shape after being filled with silicone oil;

A wire mesh 2 wrapped or cast in an inner wall of a silicone rubber membrane, said wire mesh 2 comprising: a first wire 21 disposed in a direction perpendicular to the eye axis and a second wire 22 disposed in the direction perpendicular to the eye axis, the first wire and the second wire intersecting to form a lattice; each metal wire is made of titanium alloy, and the component is Ti-5Al, belongs to alpha-type titanium alloy, and is subjected to annealing treatment to form weak elasticity. The elasticity of the material is better than that of pure titanium, the toughness of the material is weaker than that of other quenched component titanium alloy, and the material has strong folding endurance under the condition of ultra-fine (10-100 mu m). The material has the advantages of medical metal (magnetism resistance, nontoxicity and non-interference property when in contact with cells), and integrates the advantages of weak elasticity, foldability and folding resistance of the material; the function of the metal wire is to change the defect of adding silicone oil, the metal wire is distributed in the weak retina induction area, and when the micro elastic membrane expands, the resistance of the position is slightly strong and the visual axis direction is slightly weak, so that the shape of the added vitreous body is expanded in a similar way and is matched with the developed and grown intraocular tissue;

A valve 3, also called an internal sealing valve, is provided at the port of the silicone rubber membrane, as shown in fig. 10a and 10b, said valve having a through hole 31 therethrough and a side wall 33 surrounding said through hole; the through hole is communicated with the internal closed space, and the side wall surrounding the through hole is provided with an elastic sealing surface for sealing or closing a channel for injecting silicone oil; the inner sealing valve is made of silica gel, and the thickness of the inner sealing valve is not more than 5mm. The installation position corresponds to the blind retina part, and the blind retina part is adhered to the interior of the micro elastic membrane;

An auxiliary tube 4, as shown in fig. 11, 12a and 12b, is translatably arranged in the valve 3 (internal sealing valve), the auxiliary tube 4 comprising: a tubular body 49 and a sealing end 41 connected to the tubular body, the tubular body having a fluid filling port 470, a fluid passage 47 and a passage outlet 475, the fluid filling port 470, the fluid passage 47 and the passage outlet 475 being in communication with each other, the fluid passage 47, the passage outlet 475 being not in communication with the sealing end 41; the sealing end 41 is internally provided with an adjusting hole 43, the adjusting hole 43 is provided with an inlet end 435 and an outlet end 431, the inlet end 435 is positioned at one end of the sealing end, which is close to the fluid filling port 470, the outlet end 431 is positioned at one end, which is far away from the fluid filling port 470, and can extend to the outer surface of the sealing end or can be sealed in the sealing end, and when silicone oil needs to be injected, the sealing end is pierced through the adjusting hole 43 by a needle. The adjustment aperture 43 is tapered with the inlet end 435 being larger in diameter than the outlet end 431 for filling.

Further, as shown in fig. 11, the outer edge of the sealing end 41 is further provided with a cutting groove 45 for cutting the tubular body 49, so that the tubular body 49 is cut after the silicone oil is injected when the artificial vitreous body device is implanted; the cutoff slot 45 is spaced from the fluid fill port 470 more than the channel outlet 475 is spaced from the fluid fill port 470.

Further, according to fig. 4, 5 and 6, the wire mesh 2 is distributed on the silicone rubber film in a region corresponding to the weak feel region of the retina. This does not affect imaging of the fovea and surrounding areas. In addition, the width of the single wire of the wire mesh is in the range of 50-100 mu m, the theoretical interference is far smaller than the influence of blind spots, and the compensatory effect of the visual cells further compensates the interference. The wire mesh 2 can be made and positioned according to the method of fig. 8 a.

Further, as shown in fig. 11, the sealing end 41 includes: first sealing ball 411 and second sealing ball 413, first sealing ball 411 are spherical, and second sealing ball 413 is hemispherical, and first sealing ball 411 and second sealing ball 413 are the silica gel ball to be convenient for two-way seal, second sealing ball 413 is connected with tubular main part 49, sealed end 41 still includes: the transition connection section 412 is connected between the first sealing ball 411 and the second sealing ball 413, the transition connection section 412 is in a necking state, the main body is cylindrical, the diameters of the first sealing ball 411 and the second sealing ball 413 are equal, the diameter of the transition connection section 412 is smaller than that of the first sealing ball or the second sealing ball, the auxiliary pipe is made of silica gel, the outer diameter of the main body is slightly larger than the inner diameter of the through hole of the inner sealing valve, and the sealing effect is slightly ensured due to certain deformation and restoration capacity of the silica gel. Such a construction facilitates movement of the auxiliary tube 4 and also facilitates sealing of the auxiliary tube 4 by the internal sealing valve.

Further, as shown in fig. 11, 12a, 12b and 12c, the inlet 435 is located in the second sealing ball 413, and the outlet is located in the first sealing ball, so as to facilitate sealing and injection of silicone oil.

Further, as shown in fig. 10a, 12b, 12c, the diameter of the tubular body 49 is larger than the diameter of the narrowest part of the through hole 31 to achieve an effective seal.

Further, as shown in fig. 10a, 12b and 12c, the side wall 33 surrounding the through hole is in an arch shape or an arc shape protruding toward the axial direction of the through hole, that is, the inside of the internal sealing valve is provided with a protrusion to form a sealing arch body, so that a gradient seal can be formed.

Further, the fluid filling port 470 is located in the axial direction of the tubular body 49, the passage outlet 475 is located in the lateral direction of the tubular body 49, and the cutoff groove 45 is located between the inlet end 435 and the passage outlet 475. Thus, silicone oil is injected from the end and flows out of the tubular body 49 from the side into the silicone rubber membrane 1, firstly, the length of the tubular body 49 is reduced, and secondly, the silicone oil can be skillfully sealed and later injection is facilitated.

Further, the first metal wire or the second metal wire adopts titanium alloy metal wires with the thickness of 50 μm and the width of 100 μm, and the mesh size of the metal wire mesh is as follows: 1mm long and 1mm wide. The first wire arranged along the direction perpendicular to the eye axis is annular, and the curve diameter of the annular shape is 25mm. As shown in FIGS. 3a and 3b, if the circumferential direction is deformed by 1mm, the circumferential stress is known from the formula (1)5.6MPa. From the formula (2), the working pressure in the ring under the deformation is 0.45MPa, namely 450KPa. The comparison of normal intraocular pressure range of 1.33-2.80 KPa shows that the thickness of the metal ring designed by the invention can fully bear the eye pressure capability, namely, when the intraocular pressure slightly changes, the deformation of the metal ring is weak, and the pressure can be absorbed or released by the micro elastic membrane.

1. Principle of the method

The invention provides an artificial vitreous body with weak elastic support by using a wire mesh, and after the artificial vitreous body is implanted into the eyeball, silicone oil is filled into the eyeball so that the artificial vitreous body is in gentle contact with retina. The diameter of the vitreous imitation ball can be regulated within 1.5 cm-2.0 cm, and is suitable for the development requirement of children suffering from the ocular brain kidney syndrome. The invention combines the weak elasticity principle of the wire mesh and the autonomic regulation principle of the optic nerve, designs an artificial vitreous body suitable for the infant with the ocular brain kidney syndrome, creates conditions for the eye ball and vision development of the infant with the ocular brain kidney syndrome, and also strives for time for brain development and subsequent treatment.

(1) Weak elasticity principle of metal ring support

The weak elastic design of the wire mesh enables the artificial vitreous body to have fine adjustment capability, can be closely contacted with retina and can adaptively adjust intraocular pressure. The metal wire mesh is cast in silica gel and fused with the vitreous film into a whole, the width of the metal wire is 100 mu m, the thickness of the metal wire is 50 mu m, and the simple net structure has the capability of supporting retina and intraocular pressure variation amplitude.

From mechanical knowledge, the metal ring (fig. 3a and 3 b) is subjected to circumferential stress in the elastic rangeAs shown in formula (1). Set circumferential deformation asAxially non-deformed, the metal elastic modulus is E, the Poisson ratio is mu, and then:

the circumferential stress to which the metal ring shown in FIG. 3 (b) is subjected can also be deduced by differentiation Is of formula (2). Let internal pressure be P, metal ring diameter be D, metal ring thickness be h, then:

obviously, from the formulas (1) and (2), a metal ring structure satisfying weak elasticity can be designed.

(2) Principle of visual cell compensation

The retina is the inner layer of the eye wall, divided into the blind and optic portions of the retina, see fig. 4. The blind part is attached to the inner surface of the iris and ciliary body and is an integral part of the iris and ciliary body. For detailed analysis, the optic is divided into a sensitive area centered on the macula and an adjacent weak sensitive area.

The macula is located at 0.35cm on the temporal side of the fundus optic disc and slightly below, in the optical central region of the human eye, which is the projection point of the vision axis. The depression in the center of the macula, called the fovea, is where vision is most acute.

The visual cells are also called photoreceptor cells, rod-and cone-dividing cells. Wherein: rod cells are sensitive to weak light stimuli; cone cells are sensitive to intense light and color. Cone cells are mainly concentrated in the fovea; the rods are more outward Zhou Jian from the foveal edge. The distribution of the number of cells on the retina along the distance on the retina is shown in fig. 5, the abscissa in fig. 5 is 0.1mm, and the area near the fovea is seen as the main imaging area. The disk is formed by nerve fibers at the position of 3-5 mm of the fovea, and has no photosensitive structure, so that the disk can not be imaged by photosensitive and presents blind spots. In normal activities, blind spots do not cause visual loss, not only because the area occupied by the blind spots is very small (the diameter is 5-8 degrees and the diameter is about 3-5 mm), but also because the visual cells in the adjacent parts of the blind spots show compensatory action under the condition of eyeball movement, so that the imaging consistency is maintained.

It follows that placement of the vitreous wire mesh in the region of weakness (shown in fig. 6) will not affect imaging of the fovea and surrounding areas. In addition, the width of the single wire of the wire mesh is in the range of 50-100 mu m, the theoretical interference is far smaller than the influence of blind spots, and the compensatory effect of the visual cells further compensates the interference. The invention is that

1. An artificial glass body with supporting capability and weak elasticity is provided by utilizing the weak elasticity principle of a wire mesh;

2. By utilizing the principle of autonomic regulation of optic nerve, a supporting mode of the wire mesh inside the artificial vitreous body is provided.

2. Composition structure

According to the above principle, an artificial vitreous apparatus (also called weak elastic artificial vitreous) suitable for ocular, cerebral and renal syndromes is designed, schematically shown in fig. 2. The artificial vitreous body device of the invention consists of 4 parts: micro elastic membrane (also called silicone rubber membrane), wire mesh, internal sealing valve (valve) and auxiliary tube.

(1) The structure of the artificial vitreous body device of the invention

The artificial vitreous device shown in fig. 2 is in a state after filling with silicone oil, and in a state before surgical implantation, is in a curled shape (fig. 7a and 7 b), facilitating implantation from a minimally invasive incision. The planar state of spreading is shown in fig. 7 (c).

① Micro elastic film, also called silicone rubber film

The micro elastic membrane material is medical silicon rubber, the thickness of the film is 20 mu m, and the thickness of the wrapping wire is 100 mu m. The thickness ensures good light transmittance, and has sufficient strength and slight elasticity.

The micro elastic membrane is manufactured according to the shape and the size of the vitreous body of the infant. Firstly, obtaining the vitreous body data of the infant, and establishing different infant model databases. CT imaging is adopted, orbit bones are used as outer edge limits, eyeball imaging data are gradually processed and corrected, and finally model sizes are determined. Next, a (metal) mold is processed. After the infant is analyzed, a proper model is selected, and a die is processed by a high-precision machine tool. The mould of fig. 8a is an apple-shaped upper half with an inner cavity and the mould of fig. 8b is an apple-shaped lower half with an inner cavity.

Then, a wire mesh is placed on the model of fig. 8a, and the front mold containing the weak retina induction area of fig. 8a is poured respectively to form a front (upper) micro elastic membrane containing the weak retina induction area; the rear mold containing the retinal sensitive area of fig. 8b is cast to form a rear (lower) micro elastic membrane containing the retinal sensitive area, and then the front micro elastic membrane cast from fig. 8a and the rear micro elastic membrane cast from fig. 8b are formed into the whole micro elastic membrane by bonding the positioning grooves and the positioning posts, so that the whole micro elastic membrane has an internal cavity and is unfolded into a plane shape.

② Wire mesh

The metal wire is made of titanium alloy, and the component is Ti-5Al, belongs to alpha-type titanium alloy, and is subjected to annealing treatment to form weak elasticity. The elasticity of the material is better than that of pure titanium, the toughness of the material is weaker than that of other quenched component titanium alloy, and the material has strong folding endurance under the condition of ultra-fine (10-100 mu m). The material has the advantages of medical metal (antimagnetic, nontoxic and non-interference with cell contact), and integrates the advantages of weak elasticity, foldability and folding endurance of the material.

The thickness of the metal wire is 50 μm, and the width is 100 μm. Assuming that the wire in the direction perpendicular to the eye axis is approximately annular, the curve diameter of the annular is 25mm, and if the annular deformation is 1mm, the circumferential stress is known from the formula (1)5.6MPa. From the formula (2), the working pressure in the ring under the deformation is 0.45MPa, namely 450KPa. The comparison of normal intraocular pressure range of 1.33-2.80 KPa shows that the thickness of the metal ring designed by the invention can fully bear the eye pressure capability, namely, when the intraocular pressure slightly changes, the deformation of the metal ring is weak, and the pressure can be absorbed or released by the micro elastic membrane.

The wires may be broken at the intersection points, without intersecting, so that the thickness is uniform. Since the wires are very thin (50 μm diameter), they can also be cross-overlapped and the thickness of the overlapped position can be the same as that of the monofilament. The wires are not welded, and the grid warps and wefts are crossed because the wires are very thin by 50 mu m. The whole body is poured into the film to strengthen the stress of the film. The silk screen is integrally cast into a whole after being distributed on the front mould.

Designing a metal wire: when the diameter of the glass body needs to be increased, silicone oil is slightly injected into the device under pressure, so that the micro elastic membrane expands. The conventional artificial glass initial state is shown in fig. 9 (a) in which the distance in the visual axis direction is short, called "short axis", and the distance in the visual axis perpendicular direction is long, called "long axis". The infant eye can be better fitted after initial implantation, as shown in fig. 9 (b). If the glass body peripheral space is enlarged by rapid growth, the retina and peripheral tissues collapse and the visual development is greatly influenced. The conventional artificial glass body is also made of medical silicon rubber, has certain elasticity, and can expand if silicone oil is added, so that the glass body can theoretically continue to play a supporting role. However, as shown in fig. 9 (c), the expansion is not similar to the original shape, but is longer in the major axis direction and shorter in the minor axis direction. The situation of the fit with retina is shown in fig. 9 (d), namely, a larger pressure is formed on the weak sensitive area of retina, and the visual axis direction is separated from the trend, the imaging quality of the infant is rapidly reduced due to the increase of the distance between vitreous body and the sensitive area of retina, and the lens, iris, cornea and the like are affected due to the increase of the space between lens and vitreous body.

The function of the metal wire is to change the defect of adding silicone oil, the metal wire is distributed in the weak retina area, and when the micro elastic membrane swells, the resistance of the position is slightly strong, and the visual axis direction is slightly weak, so that the shape of the glass body after filling is expanded in a similar way, and the glass body is matched with the eye tissue which grows up continuously.

③ Internal sealing valves, also known as valves or sealing valves

The inner sealing valve is made of silica gel, and the thickness of the inner sealing valve is not more than 5mm. The mounting position corresponds to the retinal blind part, which is adhered to the interior of the micro elastic membrane. The structure is schematically shown in fig. 10, the through hole allows the auxiliary tube to reciprocate, and the inside of the through hole is provided with a bulge to form a sealing arch body to form a seal with the end of the auxiliary tube.

The auxiliary pipe is made of silica gel, the outer diameter of the main pipe is slightly larger than the inner diameter of the through hole of the inner sealing valve, and the sealing effect is ensured due to certain deformation and recovery capacity of the silica gel. The structure diagram is shown in fig. 11, the main body of the auxiliary tube is a silica gel tube, and the internal through hole is a channel for injecting silicone oil. The sealing end of the auxiliary pipe is a silica gel ball, the spherical surfaces are in a necking state, and an adjusting hole is formed in the end ball and is not communicated with the fluid channel. The joint of the sealing end and the main body is provided with a cutting position groove (cutting groove) which is convenient for cutting.

The sealing process of the auxiliary pipe and the internal sealing valve is shown in fig. 12. Before the glass body is implanted, as shown in fig. 7a and 7b, the auxiliary tube is the shaft of the micro elastic film roll; the through hole 5 in fig. 7a and 7b is used for injecting silicone oil, the channel outlet 475 is the outlet of the through hole 5, the silicone oil flows into the auxiliary tube from the hole, flows out of the auxiliary tube from the channel outlet 475 and flows into the artificial vitreous body, and when the artificial vitreous body is implanted, the auxiliary tube has certain hardness, so that the artificial vitreous body is convenient to implant and position; when the silicone oil is filled, the silicone oil is injected into the main body end of the pipe by the injector, so that the coiled glass body is gradually unfolded. The auxiliary tube state after the implantation and positioning of the glass body and when the silicone oil is filled is shown in fig. 12 (a).

After the glass body is filled with the designed amount of silicon oil, the auxiliary tube is pulled out to seal the necking part of the sealing end with the inner sealing valve arch body, as shown in fig. 12 (b). The auxiliary pipe is cut off in the cut-off position groove (cut-off groove), and the cutting surface is positioned inside the end face of the inner sealing valve, as shown in fig. 12 (c). At this time, the adjusting hole is still in a closed state, and if the amount of silicon oil in the vitreous body is necessary to be adjusted, the hole can be pierced by a syringe and a fine needle; after the injection is completed, the fine needle is pulled out, and the hole is closed by itself.

3. Working process

The following describes the process of making and surgically implanting a weak elastic artificial vitreous.

① Manufacturing process

The manufacturing process is the same as that of the micro elastic film.

The special points are as follows: the design needs to be considered, and the actual conditions, development states and operation expectations of infants are considered. The diameter of the infant eyeball is in the range of 12-15 mm, and the diameter of the human eyeball is about 25mm. Considering the development condition of the infant with the syndrome of eyes, brain and kidney, the artificial vitreous body has the adjusting capacity of +3-5 mm, and the natural development period of 3-5 years is provided for the infant without the operation of replacing the vitreous body.

② Surgical implantation procedure

The surgical implantation process is substantially the same as the existing folded artificial vitreous surgical procedure.

A. After treatment of the vitreous and the stock solution in the eye, fig. 13a;

b. incision was made at the weak sensory area of retina by a conventional surgical standard, the incision being about 4mm; implanting a weak elastic artificial vitreous ball in a rolled state into the eyeball, fig. 13b;

c. slowly injecting silicone oil into the micro elastic membrane by using an injector through the auxiliary tube, and gradually expanding the coiled micro elastic membrane, wherein an operator can shake the auxiliary tube slightly at the moment, so that the expanded artificial vitreous body is more easily contacted with retina accurately; after the glass body is basically fully unfolded and all directions meet the design requirements, slowly pulling out the auxiliary tube until the cross section groove of the auxiliary tube is visible. FIG. 13c;

d. At this time, the intraocular pressure of the child suffering from the operation is monitored, and under the condition that the intraocular pressure value is slightly higher than the normal intraocular pressure value, the auxiliary valve is pulled, so that the sealing end face is closely matched with the inner sealing valve, the self-sealing effect is achieved, and the intraocular pressure is recovered to be normal at this time. The auxiliary tube is cut at the cut-off site, and the incision is sutured, suturing the inner seal valve inside the sclera. The operation is completed, and the effect is shown in fig. 13d.

E. If the intraocular pressure is continuously low after a period of time after the implanted infant suffering from the ocular, cerebral and renal syndrome is found, whether the artificial vitreous body is smaller or not can be judged, and the retina cannot be supported. If the adjustment design is within the expected adjustment design range, the adjustment of the glass body can be performed. After the position of the inner sealing valve is determined, silicone oil is supplemented into the adjusting hole of the inner sealing valve by a fine needle of the injector, the expansion state of the micro elastic membrane is determined according to the design quantity, and meanwhile, the adjusting state is judged through intraocular pressure monitoring. After the requirement is met, the thin needle is pulled out, and the sealing end can achieve the effect of sealing the needle hole by means of self elasticity.

The invention has the following advantages:

2. Under the autonomous regulation of ocular cells and optic nerves on retina, such as eyeball muscle and brain adaptability, the metal wire mesh (after silicone oil is filled) with spiral supporting structure has weakened shading effect and even no influence;

3. An artificial vitreous body suitable for children suffering from the eye-brain-kidney syndrome is designed. The valve adapts to the change of 1.5 cm-2.0 cm of the eyeball diameter of the child, the intraocular pressure bearing range is +/-2 KPa, and the self-sealing valve avoids the abrasion phenomenon of the valve in the prior art;

4. The invention can be implemented by slightly modifying the existing operation method, and the operation method has strong learning and adaptability.

The invention combines the weak elasticity principle of the wire mesh and the autonomic regulation principle of the optic nerve, designs the artificial vitreous body suitable for the infant with the ocular brain kidney syndrome, creates conditions for the eye ball and vision development of the infant with the ocular brain kidney syndrome, and also strives for time for brain development and subsequent treatment.

The foregoing is illustrative of the present invention and is not to be construed as limiting the scope of the invention. In order that the components of the invention may be combined without conflict, any person skilled in the art shall make equivalent changes and modifications without departing from the spirit and principles of the invention.

Claims

1. An artificial vitreous body device suitable for infants suffering from ocular, cerebral and renal syndromes, characterized in that the artificial vitreous body device suitable for infants suffering from ocular, cerebral and renal syndromes comprises:

a wire mesh cast within an inner wall of a silicone rubber membrane, the wire mesh comprising: a first metal wire arranged along the direction vertical to the eye axis and a second metal wire arranged along the direction vertical to the eye axis, wherein the first metal wire and the second metal wire are intersected into a grid shape; each metal wire is made of titanium alloy;

An auxiliary tube translatable within the valve, the auxiliary tube comprising: the sealing device comprises a tubular main body and a sealing end connected with the tubular main body, wherein the tubular main body is provided with a fluid filling port, a fluid channel and a channel outlet, the fluid filling port, the fluid channel and the channel outlet are communicated with each other, and the fluid channel and the channel outlet are disconnected from the sealing end; an adjusting hole is formed in the sealing end, the adjusting hole is provided with an inlet end and an outlet end, the inlet end is positioned at one end, close to the fluid filling port, in the sealing end, and the outlet end is positioned at one end, far away from the fluid filling port;

The outer edge of the sealing end is also provided with a cutting groove for cutting off the tubular main body, and the distance between the cutting groove and the fluid filling port is larger than that between the channel outlet and the fluid filling port;

The sealed end includes: first sealing ball and second sealing ball, first sealing ball is spherical, and the second sealing ball is hemispherical, the second sealing ball is connected with tubular main part, sealed end still includes: the transition connecting section is connected between the first sealing ball and the second sealing ball, the main body of the transition connecting section is cylindrical, the diameters of the first sealing ball and the second sealing ball are equal, and the diameter of the transition connecting section is smaller than that of the first sealing ball or the second sealing ball.

2. The artificial vitreous apparatus for infants suffering from ocular cerebro-renal syndrome of claim 1, wherein the wire mesh is distributed on the silicone rubber membrane in a region corresponding to the weak sensory area of the retina.

3. The artificial vitreous apparatus of claim 1, wherein the inlet end is located in the second sealing sphere and the outlet end is located in the first sealing sphere.

4. The artificial vitreous body device for use in children suffering from ocular cerebro-renal syndrome of claim 1, wherein the diameter of the tubular body is greater than the diameter of the narrowest of the through-holes.

5. The artificial vitreous body device for children with ocular cerebro-renal syndrome of claim 1, wherein the sidewall surrounding the through hole is an arch protruding toward the axial direction of the through hole.

6. The artificial vitreous body device of claim 1, wherein the fluid filling port is located axially of the tubular body, the channel outlet is located laterally of the tubular body, and the cutoff slot is located between the inlet end and the channel outlet.

7. The artificial vitreous body device for children with ocular cerebro-renal syndrome of claim 1, wherein the first wire is formed in a ring shape along a direction perpendicular to the ocular axis, and the diameter of the ring-shaped curve is 25mm.

8. The artificial vitreous apparatus for children with ocular, cerebral and renal syndrome of claim 1, wherein the first wire or the second wire is a wire having a thickness of 50 μm and a width of 100 μm, and the mesh size of the wire mesh is: 1mm long and 1mm wide.