CN213250327U - Device for filling silicone oil into artificial glass body - Google Patents
Device for filling silicone oil into artificial glass body Download PDFInfo
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- CN213250327U CN213250327U CN202021090921.9U CN202021090921U CN213250327U CN 213250327 U CN213250327 U CN 213250327U CN 202021090921 U CN202021090921 U CN 202021090921U CN 213250327 U CN213250327 U CN 213250327U
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Abstract
The utility model provides a device to artifical vitreous body filling silicon oil, device to artifical vitreous body filling silicon oil includes: the valve is arranged at the port of the silicon rubber film; an auxiliary tube translatably disposed in the valve, the auxiliary tube comprising: the sealing structure 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 passage and a passage outlet, the fluid filling port, the fluid passage and the passage outlet are communicated with each other, an adjusting hole is arranged in the sealing end, the adjusting hole is provided with an inlet end and an outlet end, the inlet end is located in the sealing end and close to one end of the fluid filling port, and the outlet end is located at one end far away from the fluid filling port. Utilize the utility model discloses, can realize still can adjust the shape and the intraocular pressure of artifical vitreous through injecting silicon oil after implanting artifical vitreous.
Description
Technical Field
The utility model relates to the field of ophthalmic medical equipment, concretely relates to device for filling silicone oil into artificial glass body.
Background
The eye-brain-kidney syndrome is also called Lowe syndrome, and is a rare sexually-linked recessive genetic disease. Clinically, the traditional Chinese medicine is characterized by congenital cataract, low intelligence and renal tubular acidosis, defects exist at birth, but symptoms mostly appear in infancy or later. Eye, brain and kidney diseases may also occur at different ages.
The ocular symptoms of Lowe syndrome are: congenital bilateral cataracts with congenital glaucoma; vitreous opacity, severe visual impairment, light sensation only or complete blindness; there are large nystagmus and photophobia.
The Lowe syndrome can be divided into infancy, childhood and adulthood according to the natural course of disease. In infancy, the eye diseases are characterized by various eye abnormalities and cranial deformities, the eye diseases are common in congenital cataract and congenital glaucoma, and can be accompanied by eye shake, eyeball floating movement and blindness, and the eye diseases are often diagnosed due to blindness, various cranial deformities such as long head restraint, forehead high process, saddle nose, high faucial arch and the like can appear, and the eye diseases are accompanied by serious mental retardation, low muscle tension and weakened or disappeared tendon reflex. Nervous system manifestations such as hyperexcitability, shouting and even general convulsions can occur. No abnormal kidney manifestations exist in this stage, but obvious rickets signs can appear.
The analysis shows that the eye abnormality, the congenital cataract, the vitreous opacity and the like of the infants can cause serious obstruction to the environmental perception, thereby aggravating the symptoms of low intelligence and the like. Among the overall treatment regimens, early treatment of ocular diseases is preferred.
In the treatment of eye diseases, cataract treatment is easily regarded, and surgical treatment methods are well established, while the condition of vitreous opacity is not regarded sufficiently. The reason is because the degree of vitreous opacity in infancy is relatively weak relative to the effects of cataracts; secondly, the existing vitreous opacity treatment method has more problems. However, the effects of vitreous opacity are prominent after surgical treatment of cataracts.
The existing vitreous opacity treatment methods mainly comprise two methods:
(1) silicone oil filling method. Since the silicone oil has the characteristics of good light transmission and little damage to human bodies, the silicone oil substances are widely applied in the medical field. After the vitreous body is turbid, the turbid colloidal liquid is extracted and filled with silicone oil for replacement, and the method is suitable for the condition that the retina is not damaged. The therapeutic effect was good in a short time, but the emulsification of silicone oil was observed for a long time (after 6 months), especially with the lens, and the lens was damaged. The longer the time is, the more obvious the silicone oil emulsification phenomenon is, and complications such as corneal zonal degeneration, corneal endothelial decompensation, secondary glaucoma and the like can be caused. After the complication is serious, only the silicone oil can be selected to be removed, and then the phenomenon of eyeball atrophy cannot 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 implant method. With the progress of the related technology, the artificial vitreous body in the shape of a silica capsule is gradually used at present, and the artificial vitreous body is implanted into the eyeball to replace the original vitreous body. The foldable artificial vitreous body with better application effect is taken as an example for explanation, and is made of silicon rubber and consists of a sacculus, a drainage tube and a drainage valve. The operation method (see fig. 1a, 1b, 1c, 1d, 1e and 1f) is that after the vitreous body and the stock solution in the eyeball are treated, the folding vitreous body balloon is implanted into the eye through a 4mm incision on the surface of the eyeball, silicone oil is injected into the balloon, and the balloon is expanded until being contacted with the retina, so that the intraocular filling effect is achieved. The advantages are that: the silicone oil is wrapped by the balloon material, the emulsification hardly occurs, and the silicone oil is isolated from the intraocular tissue by the balloon material, so that the complication of the original silicone oil in the eyes is avoided. The treatment method has made certain progress and is popularized and applied.
From the above analysis, although the silicone oil filling method is simple, long-term application thereof causes many complications. The artificial vitreous body implantation method well solves the problems and has good development prospect. However, it can still be seen from the operation method that the artificial vitreous body needs to be customized by a single person, in order to prevent the vitreous body from causing larger pressure on the retina, the volume and the shape of the silicone oil filled in the artificial vitreous body are still slightly smaller than those of the actual vitreous body, and the supporting effect on the retina is not good; in order to adjust the pressure of the filled silicone oil, the drainage tube and valve are fixed outside the sclera, with potential abrasion effect.
As most of patients with the eye-brain-kidney syndrome are infants, eyeballs are in a rapid development stage, the appearance and the volume of the existing artificial vitreous body are difficult to adapt, the pressure for filling silicon oil needs to be adjusted, children with the eye-brain-kidney syndrome are difficult to match, and whether the intraocular pressure is adaptive or not cannot be determined, so that new injuries are 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 adapt to adjustment.
SUMMERY OF THE UTILITY MODEL
The utility model provides a device to artifical vitreous body filling silicon oil to solve current artifical vitreous body after the implantation, appearance and volume are difficult to adapt to patient's development requirement, the unable problem that adapts to the adjustment of intraocular pressure.
Therefore, the utility model provides a device to artifical vitreous body filling silicon oil, artifical vitreous body includes: the silicone rubber membrane is provided with a port for filling silicone oil and an internal closed space connected with the port, is in a membrane shape when being unfolded into a plane, and is spherical after being filled with the silicone oil;
the device for filling silicone oil into the artificial vitreous body comprises:
the valve is arranged at the port of the silicon rubber membrane and is provided with a through hole and a side wall surrounding the through hole; the through hole is communicated with the space with the closed interior, and the side wall surrounding the through hole is provided with an elastic sealing surface;
an auxiliary tube translatably disposed in the valve, the auxiliary tube comprising: a tubular body and a sealing end connected with the tubular body, wherein the tubular body is provided with a fluid filling port, a fluid passage and a passage outlet, the fluid filling port, the fluid passage and the passage outlet are communicated with each other, and the fluid passage and the passage 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.
Furthermore, the outer edge of the sealing end is also provided with a cut-off groove for cutting off the tubular main body, and the distance between the cut-off groove and the fluid filling port is greater than the distance between the channel outlet and the fluid filling port.
Further, the adjusting hole is conical.
Further, the sealing end comprises: first ball sealer and second ball sealer, first ball sealer be spherical, and the second ball sealer is the hemisphere, the second ball sealer is connected with pipy main part, the 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.
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 larger than the diameter of the narrowest part of the through hole.
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 the axial direction of the tubular body, the passage outlet is located in the lateral direction of the tubular body, and the cut-off groove is located between the inlet end and the passage outlet.
Further, the apex angle of the conical shape is 10 degrees to 30 degrees.
Further, the tubular main body is in a circular tube shape.
The utility model has the advantages of it is following:
after the glass body is filled with the designed silicon oil, the auxiliary pipe is pulled out, so that the necking part of the sealing end and the arch body of the valve (inner sealing valve) form sealing. And (4) cutting off the auxiliary pipe at the cut-off position groove (cut-off groove), wherein the cutting surface is positioned inside the end surface of the inner seal valve. The adjusting hole is still in a closed state, and if the amount of silicone oil in the glass body needs 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.
The conditioning of the vitreous body can be carried out by injecting silicone oil if it is within the expected regulatory design. The operation does not need incision, after the position of the internal seal valve is determined, silicone oil is supplemented into the adjusting hole of the internal seal valve by using a fine needle of an injector, the expansion condition of the micro-elastic membrane is determined according to the design amount, and meanwhile, the regulation state is judged through intraocular pressure monitoring. After the requirement is met, the fine needle is drawn out, and the effect of sealing the needle hole can be achieved by the sealing end depending on the elasticity of the sealing end.
Utilize the utility model discloses, can realize still can adjust the shape and the intraocular pressure of artifical vitreous through injecting silicon oil after implanting artifical vitreous, moreover, after injecting silicon oil, can realize self-sealing, can realize the swift cutting of the tubulose main part of unnecessary length, avoid or reduced the tubulose main part of unnecessary length and stay the adverse effect to people in people's eye.
Drawings
FIG. 1a is a schematic cross-sectional view of an eyeball structure;
FIG. 1b is a schematic diagram of a prior art artificial vitreous body;
FIG. 1c is a schematic view of the prior art cleaning principle for the anterior eye portion of an artificial vitreous body;
FIG. 1d is a schematic view of a prior art artificial vitreous body implanted into an eyeball;
FIG. 1e is a schematic diagram of the silicone oil filling of the artificial vitreous body according to the prior art;
FIG. 1f is a schematic diagram of the positioning principle of a drainage tube and a valve after silicone oil is filled in the artificial vitreous body in the prior art;
FIG. 2 is a schematic view of the artificial vitreous body device of the present invention filled with silicone oil;
FIG. 3a is a schematic view of hoop stress of a metallic ring;
FIG. 3b is a dimension parameter of the metal ring;
FIG. 4 is a schematic diagram of the division of the retina area of an eyeball;
FIG. 5 is a schematic view of the distribution of visual cells on the retina;
fig. 6 is a schematic view of a wire mesh of the present invention in position on the retina;
fig. 7a is a front view of the artificial vitreous body device of the present invention in a rolled state prior to surgical implantation;
FIG. 7b is a schematic side view of the artificial vitreous device of FIG. 7 a;
FIG. 7c is a schematic structural view of the artificial vitreous body of the present invention in an expanded state prior to surgical implantation;
FIG. 8a is a schematic diagram of the operation of an anterior mold containing a retinal weak zone for making the inventive micro-stretch film;
FIG. 8b is a schematic diagram of the operation of a posterior mold containing a retina sensitive area for making a micro-ballistic membrane of the present invention;
FIG. 9a illustrates an initial state of a conventional artificial vitreous body;
FIG. 9b illustrates a prior art artificial vitreous body initially implanted in the eye in a better fit condition;
FIG. 9c is a schematic diagram showing the deformation tendency of the conventional artificial glass body when silicone oil is injected;
FIG. 9d is a schematic view showing the effect of the artificial vitreous body filled with silicone oil and then fitted to the eye;
FIG. 10a is a schematic side view of the valve of the present invention;
fig. 10b is a schematic view of the valve of the present invention;
fig. 11 is a schematic front view of the auxiliary tube of the present invention;
fig. 12a is a schematic structural view of the auxiliary pipe in the valve according to the present invention;
fig. 12b is a schematic structural view of the auxiliary tube pull-out valve of the present invention;
fig. 12c shows the sealing state of the valve after the auxiliary tube is cut off;
FIG. 13a is a schematic view of the cleaning operation of the artificial vitreous body device of the present invention prior to implantation;
FIG. 13b is a schematic view of the artificial vitreous body device of the present invention in an implanted state in the eye;
FIG. 13c is a schematic diagram of the operation of silicone oil filling of the artificial vitreous body device of the present invention;
fig. 13d is a schematic structural diagram of the artificial vitreous body device filled with silicone oil according to the present invention.
The reference numbers illustrate:
1. silicone rubber films (micro-stretch films); 2. a wire mesh; 3. valves (internal seal valves); 4. an auxiliary tube; 5. a through hole;
21. a first wire; 22. a second wire; 31. a through hole; 33. a side wall;
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. a cut-off groove; 47. a fluid channel; 470. a fluid fill port; 475. a channel outlet; 49. a main body.
Detailed Description
In order to clearly understand the technical features, objects and effects of the present invention, the present invention will now be described with reference to the accompanying drawings.
As shown in fig. 2, fig. 7a, fig. 7b and fig. 7c, the artificial vitreous body device suitable for children with eye-brain-kidney syndrome of the present invention comprises:
the silicone rubber membrane 1, also called a micro-elastic membrane, is a thin membrane, the thickness of the simple membrane is 20 μm, which exceeds the thickness of the conventional artificial vitreous body (10 μm), and the aim is to increase the pressure resistance degree, ensure that the diameter of the vitreous body is increased (1.5-2.2cm) in the later period, and ensure that the service life is not less than 5 years. The silicone rubber membrane 1 is provided with a port for filling silicone oil and an internal closed space for connecting the port, 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 the silicone oil;
a wire mesh 2 wrapped or cast within the inner wall of the silicone rubber membrane, the wire mesh 2 comprising: a first metal wire 21 arranged along the direction vertical to the eye axis and a second metal wire 22 arranged along the direction of the eye axis, wherein the first metal wire and the second metal wire are intersected to form a grid shape; each metal wire is made of a titanium alloy material, the component of the metal wire is Ti-5Al, the metal wire belongs to alpha-type titanium alloy, and the metal wire is annealed and has 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 resistance under the condition of superfine (10-100 mu m). The material not only has the advantages of medical metal (such as antimagnetic, non-toxic and non-interference with cell contact), but also integrates 3 advantages of weak elasticity, folding and folding resistance of the material; the metal wires are distributed in the retina weak sensing area, when the micro elastic membrane expands, the resistance at the position is slightly strong, and the visual axis direction is slightly weak, so that the shape of the injected vitreous body expands in a similar way and is continuously matched with the grown intraocular tissues;
as shown in fig. 12a and 12b, the device for filling silicone oil into artificial vitreous body of the present invention comprises: a valve and an auxiliary pipe.
A valve 3, also called an internal seal valve, disposed at the port of the silicone membrane, as shown in fig. 10a and 10b, said valve having a through hole 31 therethrough and a sidewall 33 surrounding said through hole; the through hole is communicated with the space with the closed interior, and the side wall surrounding the through hole is provided with an elastic sealing surface for sealing or closing a channel for injecting silicon oil; the inner sealing valve is made of silica gel and is not more than 5mm thick. The installation position of the micro elastic membrane corresponds to the retina blind part and is adhered to the inside of the micro elastic membrane;
an auxiliary tube 4, shown in fig. 11, 12a and 12b, is translatably arranged in said valve 3 (internal seal valve), said 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 passageway 47 and a passageway outlet 475, the fluid filling port 470, the fluid passageway 47 and the passageway outlet 475 being in communication with each other, the fluid passageway 47, the passageway outlet 475 not being in communication with the sealing end 41; an adjusting hole 43 is formed in the sealing end 41, the adjusting hole 43 has an inlet end 435 and an outlet end 431, the inlet end 435 is located at one end of the sealing end close to the fluid filling port 470, the outlet end 431 is located at one end far away from the fluid filling port 470, the outlet end 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, a needle can penetrate through the adjusting hole 43 to puncture the sealing end. The adjustment hole 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 main body 49, so that when the artificial vitreous body device is implanted, silicone oil is injected, and then the tubular main body 49 is cut; the cut-off groove 45 is spaced further from the fluid filling port 470 than the channel outlet 475 is spaced from the fluid filling port 470.
Further, as shown in fig. 4, 5 and 6, the wire-net 2 is distributed on the silicone rubber membrane at the area corresponding to the weak retina area. This does not affect the imaging of the fovea and surrounding areas. In addition, the width of a single metal wire of the metal wire mesh is within the range of 50-100 mu m, the theoretical interference is far smaller than the influence of a blind spot, and the interference is further compensated by the compensation effect of visual cells. The production and positioning of the wire mesh 2 can be made according to the method of fig. 8 a.
Further, as shown in fig. 11, the sealing end 41 includes: first ball 411 and second ball sealer 413, first ball sealer 411 is spherical, and second ball sealer 413 is the hemisphere, and first ball sealer 411 and second ball sealer 413 are the silicone ball to two-way sealing, second ball sealer 413 is connected with tubular main part 49, sealing end 41 still includes: the transition connection section 412 of connection between first sealing ball 411 and second sealing ball 413, transition connection section 412 is the necking down state, and the main part is cylindrical, and the diameter of first sealing ball 411 and second sealing ball 413 equals, and the diameter of transition connection section 412 is less than the diameter of first sealing ball or second sealing ball, and the auxiliary tube is the silica gel material, and the external diameter of pipe of main part slightly is greater than interior valve through-hole internal diameter, has certain deformation and resilience because of silica gel, and the diameter is slightly big guarantees sealed effect. Such a configuration facilitates the movement of the auxiliary tube 4 and also facilitates the sealing of the internal seal valve to the auxiliary tube 4.
Further, as shown in fig. 11, 12a, 12b, and 12c, the inlet port 435 is located in the second sealing ball 413, and the outlet port is located in the first sealing ball, so as to facilitate sealing and injecting 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 effective sealing.
Further, as shown in fig. 10a, 12b, and 12c, the side wall 33 surrounding the through hole is formed in an arch shape or an arc shape protruding in the axial direction of the through hole, that is, a sealing arch body is formed by providing a protrusion inside the inner seal valve, 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 cut-off groove 45 is located between the inlet port 435 and the passage outlet 475. Therefore, the silicone oil is injected from the end part and flows out of the tubular main body 49 from the side direction to enter the silicone rubber membrane 1, so that the length of the tubular main body 49 is reduced, and the silicone oil can be ingeniously sealed and is beneficial to later silicone oil injection.
Further, the first metal wire or the second metal wire is a titanium alloy metal wire with the thickness of 50 μm and the width of 100 μm. The first metal wire arranged along the direction vertical to the axis of the eye is annular, and the diameter of the curve of the annular shape is 25 mm. As shown in FIGS. 3a and 3b, when the hoop direction is deformed by 1mm, the hoop stress is known from the formula (1)
Is 5.6 MPa. Then, the working pressure in the ring under the deformation is 0.45MPa, namely 450KPa, according to the formula (2). Normal intraocular pressure scope 1.33 ~ 2.80KPa of contrast, the explanation the utility model discloses an intraocular pressure ability can be born completely to the becket thickness, and when the intraocular pressure had slight change promptly, the becket deflection was weak, and pressure can be absorbed or release by little elastic membrane.
1. Principle of method
The utility model provides the artificial vitreous body supported by weak elasticity through the wire mesh, and fills silicon oil to the inside to make the artificial vitreous body and retina mildly contact after being implanted into the eyeball. The vitreous body simulated sphere diameter can be adjusted within 1.5 cm-2.0 cm, and is suitable for the development requirement of children with eye-brain-kidney syndrome. The utility model discloses combine together the weak elasticity principle of wire mesh and optic nerve autonomic regulation principle, the design is applicable to the artificial vitreous body of eye-brain-kidney syndrome infant, for eye-brain-kidney syndrome infant eyeball and visual development creation condition, also strives for the time for brain development and follow-up treatment.
(1) Weak elasticity principle of metal ring support
The weak elastic design of the wire mesh ensures that the artificial vitreous body has micro-regulation capability, can closely contact with retina and can adaptively regulate intraocular pressure. The metal wire mesh is cast in the silica gel and is fused with the vitreous body adhesive 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 formed simple net-shaped structure has the capability of supporting retina and intraocular pressure variation amplitude.
From the mechanics knowledge, the circumferential stress to which the metal ring (fig. 3a and 3b) is subjected in the elastic range
As shown in formula (1). Set the circumferential deformation to
No axial deformation, the metal elastic modulus is E, the Poisson ratio is mu, and then:
the circumferential stress on the metal ring shown in FIG. 3b can also be derived by differential method
Is represented by the formula (2). Let the internal pressure be P and the diameter of the metal ring beD, the thickness of the metal ring is h, then:
obviously, a metal ring structure satisfying weak elasticity can be designed by the formulas (1) and (2).
(2) Principle of cell compensation
The retina is the inner layer of the eye globe and is divided into the retinal blind and the optic, see fig. 4. The blind part is attached to the inner surfaces of the iris and the ciliary body and is a component of the iris and the ciliary body. For detailed analysis, the visual portion is divided into a sensitive zone centered on the macula lutea and adjacent hypo-sensitive zones.
The macula lutea is 0.35cm on the temporal side of the optic nerve disc of the fundus, is in the optical central area of the human eye, and is the projection point of the visual axis. The depression in the center of the macula, called the fovea, is where vision is most acute.
The visual cells are also known as photoreceptor cells, and are classified into rods and cones. Wherein: rod cells are sensitive to low light stimuli; cones are sensitive to intense light and color. Cone cells are mainly concentrated in the fovea; the rod cells increase from the foveal edge to the periphery. The distribution of the number of cells on the retina along the distance on the retina is shown in fig. 5, the abscissa unit is 0.1mm, and it can be seen that the region near the fovea is the main imaging region. The 3-5 mm part of the central fovea is an optic nerve head which is composed of nerve fibers and has no photosensitive structure, so that photosensitive imaging cannot be performed, and a blind spot is presented. In normal activities, the blind spot does not cause visual loss not only because the blind spot occupies a very small area (diameter is 5-8 degrees, about 3-5 mm), but also because the visual cells adjacent to the blind spot show compensation under the condition of eyeball motion, so that the imaging is kept consistent.
It follows that placing the vitreous wire mesh in the zone of weakness (shown in figure 6) will not affect the imaging of the fovea and surrounding areas. In addition, the width of a single metal wire of the metal wire mesh is within the range of 50-100 mu m, the theoretical interference is far smaller than the influence of a blind spot, and the interference is further compensated by the compensation effect of visual cells. The utility model discloses
1. The artificial glass body with the supporting capacity is provided by utilizing the principle of weak elasticity of a metal wire mesh, and has weak elasticity;
2. the supporting mode of the metal wire mesh in the artificial vitreous body is provided by utilizing the autonomic regulation principle of optic nerves.
2. Composite structure
According to the principle, an artificial vitreous body device (also called weak elasticity artificial vitreous body) suitable for eye-brain-kidney syndrome is designed, and a schematic view is shown in figure 2. The utility model discloses an artifical vitreous body device comprises little bullet membrane (also called silicon rubber membrane), wire mesh, through interior valve (valve) and auxiliary tube to artifical vitreous body device filling silicon oil.
(1) The structure of the artificial vitreous body device of the utility model
The artificial vitreous device shown in fig. 2 is in a state after being filled with silicone oil and in a state before surgical implantation in a curled shape (fig. 7a and 7b) to facilitate implantation from a minimally invasive incision. The spread planar state is shown in fig. 7 c.
Micro-elastic film, also called silicon rubber film
The material of the micro-elastic membrane is medical silicon rubber, the thickness of the membrane is 20 mu m, and the thickness of the position wrapping the metal wire is 100 mu m. The thickness ensures good light transmission, and has enough strength and slight elasticity.
The micro-elastic membrane is manufactured according to the shape and the size of the glass body of the infant patient. Firstly, obtaining vitreous body data of the infant patient and establishing different infant model databases. And (3) adopting CT imaging, gradually processing and correcting data by taking the orbital bone as an outer edge limit and eyeball imaging data, and finally determining the size of the model. Next, the (metal) mold is machined. And (4) selecting a proper model after analyzing the infant, and processing the mold by a high-precision machine tool. The mold of fig. 8a is the upper half of an apple shape with an internal cavity and the mold of fig. 8b is the lower half of an apple shape with an internal cavity.
Then, a wire mesh is placed on the model of fig. 8a, and the anterior mold containing the retina hypo-sensitive area of fig. 8a is respectively poured to form an anterior (upper) micro-elastic membrane containing the retina hypo-sensitive area; the posterior mold containing the retina-sensitive area of fig. 8b is cast to form a posterior (lower) micro-elastic membrane containing the retina-sensitive area, and then the anterior micro-elastic membrane cast from fig. 8a and the posterior micro-elastic membrane cast from fig. 8b are bonded by the positioning grooves and the positioning posts to form the whole micro-elastic membrane, so that the whole micro-elastic membrane has an inner cavity and is unfolded into a plane shape.
② wire mesh
The metal wire is made of a titanium alloy material, the component of the metal wire is Ti-5Al, the metal wire belongs to alpha-type titanium alloy, and the metal wire is annealed and has 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 resistance under the condition of superfine (10-100 mu m). The material not only has the advantages of medical metal (such as antimagnetic property, no toxicity and no interference with cell contact), but also integrates 3 advantages of weak elasticity, foldability and folding resistance.
The utility model discloses well wire adopts 50 mu m thickness, width 100 mu m. If the wire in the direction perpendicular to the axis of the eye is approximately annular, the diameter of the annular curve is 25mm, and if the annular shape has 1mm deformation, the circumferential stress is known from the formula (1)
Is 5.6 MPa. Then, the working pressure in the ring under the deformation is 0.45MPa, namely 450KPa, according to the formula (2). Normal intraocular pressure scope 1.33 ~ 2.80KPa of contrast, the explanation the utility model discloses an intraocular pressure ability can be born completely to the becket thickness, and when the intraocular pressure had slight change promptly, the becket deflection was weak, and pressure can be absorbed or release by little elastic membrane.
The wires may be broken at the intersections without crossing, so that the thickness is uniform. Since the wires are thin (50 μm in diameter) and can also be cross-lapped, the thickness at the overlapping position can be the same as that of the monofilaments. The metal wires are not welded, and the grids are crossed in longitude and latitude due to the fact that the metal wires are thin and 50 mu m. The whole body is poured in the film, so that the stress of the film is strengthened. And after the silk screen is arranged on the front mould, the silk screen is integrally cast into a whole.
Designing a metal wire: when the diameter of the glass body needs to be increased, silicone oil is slightly pressurized and injected into the device, and the micro-elastic membrane expands. In the initial state of the conventional artificial glass, fig. 9a shows that the distance in the visual axis direction is short and is called as the short axis, and the distance in the visual axis vertical direction is long and is called as the long axis. After initial implantation into the eye of the infant, the fit is better, see fig. 9 b. If the rapid growth makes the peripheral space of the vitreous body larger, the retina and the surrounding tissues collapse, which greatly affects the visual development. The conventional artificial vitreous body is also made of medical silicon rubber and has certain elasticity, and if silicone oil is added, the vitreous body can expand and theoretically can continue to play a supporting role. However, the effect is shown in fig. 9c, where the expansion is not similar to the original shape, but rather the major axis direction is longer and the minor axis direction is less. The condition of the lens and the retina is shown in fig. 9d, namely, larger pressure is formed on a weak retinal area, the visual axis direction is separated, the distance between the vitreous body and the sensitive retinal area is increased, the imaging quality of a child patient is rapidly reduced, and the space between the crystalline lens and the vitreous body is enlarged, so that the crystalline lens, the iris, even the cornea and the like are influenced.
The metal wire is distributed in the retina weak sensing area, when the micro elastic membrane expands, the resistance at the position is slightly strong, the visual axis direction is slightly weak, so that the shape of the injected vitreous body expands in a similar way and the vitreous body continuously cooperates with the grown intraocular tissues.
The device for filling silicone oil into the artificial vitreous body comprises: an internal seal valve and an auxiliary pipe.
The inner sealing valve is also called a valve or a sealing valve, is made of silica gel and is not more than 5mm in thickness. The installation position of the elastic membrane corresponds to the blind part of the retina, and the elastic membrane is adhered to the inside of the micro elastic membrane. The schematic structure is shown in fig. 10a and 10b, the through hole allows the auxiliary pipe to reciprocate, and the bulge is arranged inside to form a sealing arch body to form a seal with the end of the auxiliary pipe.
The auxiliary pipe is the silica gel material, and main part pipe external diameter slightly is greater than internal seal valve through-hole internal diameter, because of silica gel has certain deformation and resilience, the diameter guarantees sealed effect a little bit bigger. The structure diagram is shown in figure 11, the main body of the auxiliary tube is a silicone tube, and the inner through hole is a channel for injecting silicone oil. The sealing end of the auxiliary tube 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 which is convenient to cut.
The process of sealing the auxiliary tube with the internal seal valve is shown in figure 12. Before the vitreous body is implanted, as shown in fig. 7a and 7b, the auxiliary tube is a shaft of the micro-elastic film roll; the through hole 5 shown in fig. 7a and 7b is used for injecting silicone oil, the channel outlet 475 is an 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 the auxiliary tube has certain hardness during implantation, so that the implantation and the positioning are convenient; when silicone oil is filled, the syringe is connected to the main body of the tube and silicone oil is injected into the syringe, so that the rolled glass body is gradually unfolded. After the vitreous body is implanted and positioned and filled with silicone oil, the auxiliary tubular state is shown in fig. 12 a.
After the glass body is filled with the designed amount of silicone oil, the auxiliary tube is pulled out, so that the neck of the sealing end forms a seal with the inner seal valve arch body, and the figure 12b shows. The auxiliary pipe is cut off by the groove at the cutting position, and the cutting surface is positioned inside the end surface of the internal seal valve, as shown in figure 12 c. The adjusting hole is still in a closed state, and if the amount of silicone oil in the glass body needs 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 is a brief introduction to the fabrication of weak elastic artificial vitreous bodies and surgical implantation procedures.
Making process
The manufacturing process is the same as that of the micro elastic membrane.
The special points are as follows: the design needs to consider the actual conditions, the development state and the operation expectation of the infants. The diameter of the eyeball of the infant is 12-15 mm, and the diameter of the eyeball of the adult is about 25 mm. Considering the development condition of children with eye-brain-kidney syndrome, the artificial vitreous body has the regulation capacity of + 3-5 mm, and provides a natural development period of 3-5 years for infants without receiving a vitreous body replacement operation.
② surgical implantation procedure
The surgical implantation procedure is basically the same as the existing folded artificial vitreous body surgery procedure.
a. After treatment of the intra-ocular vitreous body and the stock solution, fig. 13 a;
b. cutting an incision in the retina feeble area by about 4mm according to the conventional operation standard; implanting the rolled weak elastic artificial vitreous body ball inside the eyeball, fig. 13 b;
c. silicone oil is slowly injected into the micro-elastic membrane by an injector through the auxiliary tube, the coiled micro-elastic membrane is gradually unfolded, and at the moment, an operator slightly shakes the auxiliary tube to ensure that the unfolded artificial vitreous body is more easily and accurately contacted with the retina; after the glass body is basically completely unfolded and all directions meet the design requirements, the auxiliary tube is slowly pulled out until the section groove of the auxiliary tube can be seen. FIG. 13 c;
d. monitor operation infant's intraocular pressure this moment, under the condition that is a little higher than normal intraocular pressure value, pull the auxiliary valve, make sealed terminal surface and interior valve cooperate closely, reach self sealss effect, the intraocular pressure resumes normally this moment. The auxiliary tube is severed at the truncation, and the incision is sutured, suturing the flap inside the sclera. The surgery is completed with the effect shown in fig. 13 d.
e. If the intraocular pressure is found to be continuously low after the infant with the eye-brain-kidney syndrome is implanted for a period of time, whether the artificial vitreous body is too small to support the retina can be judged. The conditioning of the glass body can be performed if it is within the expected regulatory design. The operation does not need incision, after the position of the internal seal valve is determined, silicone oil is supplemented into the adjusting hole of the internal seal valve by using a fine needle of an injector, the expansion condition of the micro-elastic membrane is determined according to the design amount, and meanwhile, the regulation state is judged through intraocular pressure monitoring. After the requirement is met, the fine needle is drawn out, and the effect of sealing the needle hole can be achieved by the sealing end depending on the elasticity of the sealing end.
The utility model has the advantages of it is following:
1. the weak elastic design of the metal wire mesh ensures that the artificial vitreous body has micro-regulation capability, can closely contact with retina and provide simulation support, and the matched intraocular pressure is not lower than 4 KPa; the wire mesh can not be punctured and damaged, and the titanium alloy meets the relevant medical standard. The weak elastic support prevents the phenomena of eyeball depression and the like in the conventional technology in the development process of the infant patient;
2. under the autonomous regulation of eyeball muscle and brain adaptability and the like, the shading effect of the metal wire mesh with the spiral supporting structure (after being filled with silicone oil) on visual cells and optic nerves on the retina is weakened, even no influence is generated;
3. utilize the utility model discloses, can realize still can adjust the shape and the intraocular pressure of artifical vitreous through injecting silicon oil after implanting artifical vitreous, moreover, after injecting silicon oil, can realize self-sealing, can realize the swift cutting of the tubulose main part of unnecessary length, avoid or reduced the tubulose main part of unnecessary length and stay the adverse effect to people in people's eye. The utility model can adapt to the change of the eyeball diameter of a child patient from 1.5cm to 2.0cm, the intraocular pressure bearing range is +/-2 KPa, and the valve is self-sealed, thereby avoiding the abrasion phenomenon of the valve in the prior art;
4. the utility model can be implemented by slightly changing the prior operation method, and has strong operation methodology habit and adaptability.
The utility model discloses combine together the weak elasticity principle of wire mesh and optic nerve autonomic regulation principle, the design is applicable to the artificial vitreous body of eye-brain-kidney syndrome infant, for eye-brain-kidney syndrome infant eyeball and visual development creation condition, also strives for the time for brain development and follow-up treatment.
The above description is only exemplary of the present invention, and is not intended to limit the scope of the present invention. For the utility model discloses a each component can make up each other under the condition of conflict not, and any technical personnel in the field do not deviate from the utility model discloses an equal change and the modification made under the prerequisite of the design and principle all should belong to the scope of protection of the utility model.
Claims (10)
1. A device for filling silicone oil into an artificial vitreous body, wherein the artificial vitreous body comprises: the silicone rubber membrane is provided with a port for filling silicone oil and an internal closed space connected with the port, is in a membrane shape when being unfolded into a plane, and is spherical after being filled with the silicone oil;
the device for filling silicone oil into the artificial vitreous body comprises:
the valve is arranged at the port of the silicon rubber membrane and is provided with a through hole and a side wall surrounding the through hole; the through hole is communicated with the space with the closed interior, and the side wall surrounding the through hole is provided with an elastic sealing surface;
an auxiliary tube translatably disposed in the valve, the auxiliary tube comprising: a tubular body and a sealing end connected with the tubular body, wherein the tubular body is provided with a fluid filling port, a fluid passage and a passage outlet, the fluid filling port, the fluid passage and the passage outlet are communicated with each other, and the fluid passage and the passage 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.
2. The device for filling silicone oil into artificial vitreous body according to claim 1, wherein the outer edge of said sealing end is further provided with a cut-off groove which cuts off said tubular body, said cut-off groove being located at a distance from said fluid filling port greater than the distance from said channel outlet to said fluid filling port.
3. The device for filling silicone oil into an artificial vitreous body according to claim 1, wherein said adjustment hole is conical.
4. The device for filling silicone oil into an artificial vitreous body according to claim 2, wherein said sealed end comprises: first ball sealer and second ball sealer, first ball sealer be spherical, and the second ball sealer is the hemisphere, the second ball sealer is connected with pipy main part, the 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.
5. The device for dispensing silicone oil into an artificial vitreous body of claim 4, wherein said inlet port is located within the second sealing bulb and said outlet port is located within the first sealing bulb.
6. A device for filling silicone oil to an artificial vitreous body according to claim 1, characterized in that the diameter of the tubular body is greater than the diameter of the narrowest point of said through hole.
7. A device for filling silicone oil to an artificial glass body according to claim 1, wherein the side wall surrounding the through hole is arched in a direction convex toward the axis of the through hole.
8. The device for filling silicone oil into an artificial vitreous body according to claim 2, wherein said fluid filling port is located in the axial direction of the tubular body, said passage outlet is located in the lateral direction of the tubular body, and said shut-off groove is located between the inlet end and said passage outlet.
9. The device for filling silicone oil into artificial glass according to claim 1, wherein the apex angle of the cone is 10 degrees to 30 degrees.
10. The device for injecting silicone oil into an artificial vitreous body according to claim 1, wherein said tubular body is in the shape of a circular tube.
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| CN202021090921.9U CN213250327U (en) | 2020-06-12 | 2020-06-12 | Device for filling silicone oil into artificial glass body |
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| CN202021090921.9U CN213250327U (en) | 2020-06-12 | 2020-06-12 | Device for filling silicone oil into artificial glass body |
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