Posterior sclera macular region pressure adjusting support

Abstract

The utility model relates to the field of medical treatment, in particular to a posterior sclera macular area pressure adjusting support which structurally comprises a support body which is of a foldable sector-ring-like structure. The air bags are arranged on the surface of one side of the support body; and the plurality of air guide pipes are respectively communicated with the plurality of air bags. By the aid of the pressure adjusting device, the number of times of adjusting the position of the pressure applying component can be greatly reduced, the operation process is simplified, pressure can be adjusted, and postoperative vision improvement and myopia prevention effects are greatly improved.

Description

Technical Field

[0001] The utility model relates to the medical field, in particular to a posterior scleral macular area pressure adjustment bracket. Background Art

[0002] The myopia situation among teenagers in China is severe. In 2018, the overall myopia rate among teenagers nationwide was 53.6%, and it shows an increasing trend year by year. Most modern medicine believes that high myopia is the result of the combined action of genetics and the environment. Among them, a general description of the pathological formation of myopia is that the axial malignant growth of the eyeball causes the eyeball to change from a spherical shape to an ellipsoidal shape. However, the vitreous body, retina, and optic nerve inside the eyeball cannot expand accordingly, resulting in various eye diseases, such as myopic arc spots, vitreous body diseases, abnormal pigmentation in the macular area, tilted optic disc, retinal hemorrhage, lacquer cracks, choroidal atrophy, neovascularization, visual field defects, and other complications. Currently, applying pressure to the macular area of the posterior sclera in order to inhibit the axial malignant expansion of the eyeball through physical intervention is an effective means.

[0003] However, since the macular area is located at the posterior sclera and is inconvenient to observe, traditional macular area pressure application devices have problems such as complex surgical procedures due to difficult successful positioning at one time, or unsatisfactory vision improvement effects due to non-adjustable pressure. Summary of the Utility Model

[0004] In order to accurately apply pressure to the macular area and reduce the number of position adjustments of the pressure application component, the utility model provides a posterior scleral macular area pressure adjustment bracket, including: a bracket main body, the bracket main body being a foldable fan-shaped ring structure; a plurality of air bags arranged on one side surface of the bracket main body; and a plurality of air ducts respectively communicated with the plurality of air bags.

[0005] In one or more embodiments, the air bag is configured to be arranged at the posterior pole of the eyeball and, when inflated, apply force to the corresponding macular area in the direction of the interior of the eyeball until the macular area sinks by a predetermined depth.

[0006] In one or more embodiments, the bracket main body includes: a flexible substrate, the flexible substrate being in a fan-shaped ring shape; a plurality of elastic keels, the plurality of elastic keels being arc-shaped and arranged on one side surface of the flexible substrate and arranged in a fan shape; wherein, the plurality of air bags are arranged on the other side surface of the flexible substrate, and each air bag has a corresponding elastic keel on its back surface.

[0007] In one or more embodiments, the posterior scleral macula pressure adjustment stent further includes an adjustment part, and the adjustment part includes: a plurality of columnar air bags arranged on the inner side surface of the flexible substrate, and the plurality of columnar air bags are respectively arranged between the plurality of elastic keels and are located on the narrow side of the fan-shaped ring structure; a plurality of air ducts communicating with the plurality of columnar air bags.

[0008] In one or more embodiments, the flexible substrate further includes: an avoidance part, which is recessed from the middle of the arc surface of the flexible substrate toward the center side of the flexible substrate to form an avoidance notch; a plurality of suture parts, which are respectively arranged on both sides of the flexible substrate and near the center.

[0009] In one or more embodiments, the plurality of air bags are arranged in a staggered manner.

[0010] In one or more embodiments, the opening angle of the stent body is greater than or equal to 50° and less than or equal to 60°.

[0011] In one or more embodiments, each of the air bags is hemispherical or cylindrical in the inflated state.

[0012] In one or more embodiments, the contraction diameter of each air bag is 1-3 mm, and the height when inflated to full bulge is less than or equal to 5 mm.

[0013] In one or more embodiments, a plurality of air volume indicating color rings are sequentially arranged on the circumferential side of each air bag from outside to inside, and the colors of the plurality of air volume indicating color rings are different from each other.

[0014] The beneficial effects of the present utility model include: the present utility model can greatly reduce the number of times of adjusting the position of the pressure-applying component, simplify the surgical process, and realize adjustable pressure, thereby greatly improving the postoperative vision improvement effect and myopia prevention effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] In order to more clearly illustrate the technical solutions in the embodiments of the present utility model or the prior art, the following will briefly introduce the drawings required for the description of the embodiments or the prior art. Obviously, the following drawings are only some embodiments of the present utility model. For those of ordinary skill in the art, without creative efforts, other embodiments can be obtained based on these drawings.

[0016] Figure 1 It is a schematic structural diagram of the first embodiment of a posterior scleral macula pressure adjustment stent of the present utility model;

[0017] Figure 2 It is a schematic structural diagram of the second embodiment after adding an adjustment part to a posterior scleral macula pressure adjustment stent of the present utility model;

[0018] Figure 3 This is a schematic side view structure diagram of a posterior scleral macular area pressure adjustment bracket of the present utility model;

[0019] Figure 4 This is a reference diagram of the usage state of a posterior scleral macular area pressure adjustment bracket of the present utility model in a perspective state;

[0020] Figure 5 This is a schematic diagram of an embodiment of the gas volume indicating color ring distribution of the hemispherical airbag of the present utility model;

[0021] Figure 6 This is a schematic diagram of an embodiment of the gas volume indicating color ring distribution of the cylindrical airbag of the present utility model.

[0022] The meanings of the reference numerals in the above respective drawings are as follows:

[0023] 1 - bracket main body, 1 - 1 - flexible substrate, 1 - 2 - elastic keel, 1 - 3 - avoidance part, 2 - airbag, 2 - 1 - gas volume indicating color ring, 3 - air duct, 4 - suture part, 5 - 1 - columnar airbag. Detailed implementation manners

[0024] In order to clearly understand the purpose, technical solution and advantages of the present utility model, the following further details the embodiments of the present utility model in combination with specific embodiments and with reference to the drawings.

[0025] It should be noted that all expressions using "first" and "second" in the embodiments of the present utility model are for distinguishing two entities or parameters with the same name but different, and it can be seen that "first" and "second" are only for the convenience of expression and should not be understood as a limitation to the embodiments of the present utility model, and this will not be repeated in the subsequent embodiments.

[0026] In order to be able to accurately apply pressure to the macular area and reduce the number of times of adjusting the position of the pressure - applying component, the present utility model proposes a posterior scleral macular area pressure adjustment bracket, as Figure 1As shown in the figure, it includes: a stent body 1, the stent body 1 is a foldable fan-shaped ring structure; a plurality of airbags 2 arranged on one surface of the stent body; and a plurality of air ducts 3 respectively communicating with the plurality of airbags 2. Specifically, since the posterior scleral macula pressure adjustment stent in the present utility model has a large coverage area after being unfolded, it is used to be arranged at the posterior pole of the eyeball and adapt to the shape of the eyeball. During use, only the side with the airbag 2 needs to be attached above the macula area of the posterior sclera of the eyeball, and the identity identifier of the airbag 2 corresponding to the macula area is located through OCT (optical coherence tomography) technology. Then, the airbag 2 with the determined identity identifier can be inflated through the air duct 3 to achieve accurate pressure application to the macula area. After the macula area is pressurized, it sinks inward along the axis of the eye, and the pressure applied to the macula area can be adjusted by controlling the inflation volume. In this way, the present utility model can delay the development of high myopia. For patients with macular holes, the adjustment stent can help the macular hole to close, promote the reduction of the macular hole surgery, help the patient improve eyesight, and improve visual quality; by combining OCT to observe the identity identifier of the airbag corresponding to the macula area, the position of the indentation of the adjustment stent on the posterior pole of the eyeball can be controlled more precisely, so that only the macular area sinks inward; and the arrangement of the airbags can greatly reduce the number of times of adjusting the position of the pressure application component, simplify the surgical process and realize adjustable pressure, thus greatly improving the eyesight improvement effect after surgery; moreover, the stent body 1 adopts a foldable fan-shaped ring structure. After being unfolded, its shape is similar to a fan surface, and it is strip-shaped after being folded. This design is convenient for taking and placing during the surgical process, helps to reduce the trauma incision, and reduces the surgical difficulty.

[0027] In one embodiment, the stent body 1 includes: a flexible substrate 1-1, the flexible substrate 1-1 is in a fan-shaped ring shape; a plurality of elastic keels 1-2, the plurality of elastic keels 1-2 are arc-shaped and arranged on one surface of the flexible substrate 1-1 and are arranged in a fan shape; wherein, a plurality of airbags 2 are arranged on the other surface of the flexible substrate 1-1, and each airbag 2 corresponds to an elastic keel 1-2 on the back. Specifically, the advantages of designing the substrate in a fan-shaped ring shape include: one is that more airbags can be arranged, thereby increasing the probability of the airbag being located above the macula area (corresponding to the macula area); the other is that it is easy to unfold and is more fitting to the eyeball after unfolding, and it is not easy to have relative sliding with the eyeball, and it is convenient for suture fixation; each airbag 2 corresponds to an elastic keel 1-2 on the back, so that the airbag 2 can be better supported by the elastic keel 1-2, so that the deformation of the airbag 2 during the inflation process is all towards the macula area, which helps to improve the pressure application effect on the macula area.

[0028] In one embodiment, the bracket of the present utility model further includes: an avoidance portion 1-3, which is recessed from the middle of the arc surface of the flexible substrate 1-1 toward the center side of the flexible substrate to form an avoidance notch. Specifically, the shape of the notch formed by the avoidance portion 1-3 includes, but is not limited to, a semi-circular shape, a rectangular shape or a triangular shape, and its functions include avoiding the optic nerve near the macula area and playing an auxiliary positioning role.

[0029] In one embodiment, a plurality of airbags 2 are arranged in a staggered manner. Specifically, the purpose of the staggered arrangement is to increase the probability that the airbag 2 is exactly above the macula area, thereby reducing the number of times of adjusting the position of the bracket.

[0030] In an alternative embodiment, 5 elastic keels 1-2 are provided. One is arranged radially at the center of the flexible substrate 1-1, and the other 4 are symmetrically arranged along the radial direction with the elastic keel 1-2 at the center. 3 airbags 2 are sequentially arranged along the radial direction on the elastic keel 1-2 at the center. 2 airbags 2 are sequentially arranged along the radial direction on each of the adjacent two elastic keels 1-2, and 1 airbag 2 is arranged along the radial direction on each of the two outermost elastic keels 1-2. At the same time, in the direction from the outermost elastic keel 1-2 to the center elastic keel 1-2, the setting position of each airbag 2 is located in the interval area of the airbags 2 on the adjacent elastic keels. As Figure 1 shown.

[0031] In one embodiment, the posterior scleral macula area pressure adjustment bracket of the present utility model further includes: a plurality of suture portions 4, which are respectively arranged on both sides and near the center of the flexible substrate 1-1. Specifically, the suture portion 4 is a through hole arranged on both sides and near the center of the flexible substrate 1-1, and is used to pass a suture to fix the bracket to the scleral wall of the eyeball.

[0032] In one embodiment, as Figure 2 shown, the posterior scleral macula area pressure adjustment bracket further includes an adjustment portion, and the adjustment portion includes: a plurality of columnar airbags 5-1 arranged on the inner side surface of the flexible substrate 1-1, and the plurality of columnar airbags 5-1 are respectively arranged between a plurality of elastic keels 1-2; and a plurality of air ducts (not shown) communicated with the plurality of columnar airbags 5-1. During use, the opening angle between two elastic keels is adjusted by inflating the corresponding columnar airbag 5-1, so as to realize fine adjustment of the position of the airbag 2.

[0033] In one embodiment, the opening angle of the stent body 1 is greater than or equal to 50 degrees and less than or equal to 60 degrees. Specifically, since the posterior scleral macula pressure adjustment stent of the present utility model needs to be implanted between the lateral rectus muscle and the inferior oblique muscle, in order to facilitate implantation, it needs to be curled and then sent to the designated position for deployment. Therefore, in order to facilitate deployment and ensure the conformity after deployment, the opening angle of the stent body 1 is greater than or equal to 50 degrees and less than or equal to 60 degrees. If the opening angle is less than 50 degrees, the effective area of the stent body 1 after deployment is relatively small, and the effective coverage of the eyeball is insufficient. In order to ensure that the airbag 2 maintains its original deformed size after inflation, the setting interval of adjacent airbags 2 is bound to be too close. After the stent body 1 is deployed, the number of airbags 2 corresponding to the macula area may be more than one, and the action effects between them affect and restrict each other. This not only increases the adjustment times of the airbags 2 effectively acting on the macula area, improves the adjustment difficulty, complicates the surgical process, but also is not conducive to accurately realizing the indentation depth of the macula area by controlling the inflation volume. If the opening angle is greater than 60 degrees, the effective area of the stent body 1 after deployment is relatively large, the effective coverage of the eyeball is redundant, and there is material waste. In addition, the overall folded size is too thick, which is not conducive to surgical implantation.

[0034] In an alternative embodiment, the stent body 1 is a flexible thin sheet with an opening angle of 55 degrees, an inner and outer diameter distance of 12 mm, a deployed width of 10 mm, and a thickness of 0.2 mm. The material can be optionally a tissue-compatible PVC (polyvinyl chloride) material, a PE (polyethylene) material, or a medical silicone material. The diameter of each elastic keel is 0.4 mm, and the material can be optionally titanium alloy to ensure safety in use.

[0035] In one embodiment, as Figure 3 shown, each airbag 2 is hemispherical or cylindrical in the inflated state. Specifically, the airbag can be formed by splicing two PVC layers. Specifically, the airbags 2 are hot-pressed in a staggered arrangement on one of the PVC layers in advance, and one end of the air duct is arranged inside the airbag 2, and then covered by another PCV layer and bonded into a whole (the airbag 2 part is not bonded), and part of the air duct is clamped between the two PVC layers.

[0036] In one embodiment, as Figure 3 shown, the contraction (in the non-inflated state) diameter of each airbag is 1-3 mm (optionally 1.5 mm), and the height after full inflation is less than or equal to 5 mm (optionally 3 mm or 5 mm). Specifically, for a semi-circular airbag, the height after full inflation refers to the height from its spherical vertex to the flexible substrate 1-1, which is less than or equal to 5 mm. For a cylindrical airbag, the height after full inflation refers to its column height, which is less than or equal to 5 mm. Specifically, the limitation of the airbag diameter and thickness helps to ensure the effective pressure application area and the effective pressure application to improve the vision improvement effect.

[0037] Further, the usage state of a posterior scleral macular area pressure adjustment bracket of the present utility model is as follows Figure 4 shown. The wide side (the side with the avoidance notch) of the bracket main body 1 faces the optic nerve side, and a suture part is arranged on the narrow side of the bracket main body 1 for avoiding the optic nerve during suture.

[0038] In one embodiment, as Figures 5-6 shown, a plurality of gas volume indicating color rings 2-1 are sequentially arranged on the circumferential side of each airbag 2 from outside to inside, and the colors of the plurality of gas volume indicating color rings 2-1 are different. Specifically, when the airbag is in an uninflated state, the gas volume indicating color rings 2-1 are stacked together and cannot be observed from the side. As the airbag is inflated, the gas volume indicating color rings 2-1 will slowly rise or expand elastically, so that the gas volume indicating color rings 2-1 can be observed from the side of the airbag 2, thereby judging the rising height of the airbag by observing the gas volume indicating color rings 2-1, and further assisting the doctor to judge the inflation volume. This method can avoid the problem that it is impossible to accurately judge whether the pressure applied by the airbag is appropriate through the inflation volume due to individual differences (such as retinal elasticity or thickness).

[0039] In one embodiment, the flexible substrate 1-1, the plurality of elastic keels 1-2 and the plurality of airbags 2 are all prepared from elastic materials with biocompatibility.

[0040] Surgical process embodiment

[0041] 1. Fold the bracket into a long strip shape and send it through the gap between the lateral rectus muscle and the inferior oblique muscle to the posterior part of the eyeball. Then unfold the long strip-shaped bracket so that the wider side of the fan-shaped ring structure covers the posterior pole of the eyeball centered on the macular area, and set the semi-circular opening (about 6 mm) of the avoidance part 4 at the optic nerve;

[0042] 2. Use a suture to pass through the suture part 5 to sew the bracket on the scleral wall of the eyeball;

[0043] 3. Inflate each trachea with a syringe needle respectively to make the corresponding airbag 2 expand and bulge, so as to push the corresponding part of the eyeball wall into the eyeball interior. At the same time, use OCT imaging technology to observe whether the indented part in the eyeball is the macular area. If it is not the macular area, release the inflated gas. If it is the macular area, seal the tracheal orifice by means of a plug or tying a knot to keep the airbag in an inflated and expanded state;

[0044] 4. Suture the incision, and the operation is over;

[0045] After a period of time, when the development speed of the patient's high myopia is inhibited or the macular hole is closed, release the gas in the airbag 2, and the bracket can be implanted in the eyeball all the time for subsequent observation and adjustment. The beneficial effects of the present utility model include:

[0046] 1. The bracket of the present utility model pushes the macula area of the eyeball into the eyeball from the posterior pole of the eyeball through an airbag, causing the macula area to sink inwards, so as to delay the development of high myopia; for patients with macular holes, it can help the macular holes to close, promote the reduction of macular hole surgery, help patients improve their vision and improve visual quality;

[0047] 2. After the bracket is fixed, by inflating different airbags and observing through OCT which airbag corresponds to the macula area at the same time, the position of the indentation of the bracket on the posterior pole of the eyeball can be accurately controlled, so that only the macula area sinks inwards;

[0048] 3. By controlling the amount of air inflated into the airbag, the depth of the indentation of the macula of the eyeball can be controlled;

[0049] 4. The volume after folding is small, the taking and placing operations are simple, the surgical difficulty is small, and it has a large area after unfolding and is not prone to relative sliding.

[0050] The above are the exemplary embodiments disclosed by the present utility model. However, it should be noted that various changes and modifications can be made without departing from the scope of the embodiments disclosed by the present utility model defined by the claims. The functions, steps, and / or actions of the method claims according to the disclosed embodiments herein do not need to be performed in any specific order. In addition, although the elements disclosed in the embodiments of the present utility model can be described or claimed in an individual form, they can also be understood as multiple unless explicitly limited to the singular.

[0051] Those of ordinary skill in the art should understand that: the discussion of any of the above embodiments is only exemplary and is not intended to imply that the scope of the embodiments disclosed by the present utility model (including the claims) is limited to these examples; under the idea of the embodiments of the present utility model, the technical features between the above embodiments or different embodiments can also be combined, and there are many other variations in different aspects of the embodiments of the present utility model as above, which are not provided in detail for the sake of brevity. Therefore, any omission, modification, equivalent replacement, improvement, etc. made within the spirit and principle of the embodiments of the present utility model shall be included in the protection scope of the embodiments of the present utility model.

Claims

1. A posterior scleral macular pressure adjustment bracket, characterized in that: include: A support body, wherein the support body is a foldable fan-ring-like structure; A plurality of air bags are arranged on a surface of one side of the stent body; as well as A plurality of air guide tubes are respectively connected to the plurality of air bags.

2. The posterior scleral macular pressure adjustment bracket according to claim 1, characterized in that: The airbag is configured to be disposed at the posterior pole of the eyeball and to apply force to the macular area corresponding to the airbag toward the inside of the eyeball when inflated until the macular area is sunken to a predetermined depth.

3. The posterior scleral macular pressure adjustment bracket according to claim 1, characterized in that: The support body comprises: A flexible substrate, wherein the flexible substrate is in a fan-shaped ring; A plurality of elastic keels, which are arc-shaped, disposed on one side surface of the flexible substrate and arranged in a fan shape; The plurality of airbags are arranged on the other side surface of the flexible substrate, and the back side of each airbag corresponds to the elastic keel.

4. The posterior scleral macular pressure adjustment bracket according to claim 3, characterized in that: The invention also includes an adjustment unit, wherein the adjustment unit includes: A plurality of columnar airbags are disposed on the inner side surface of the flexible substrate, and the plurality of columnar airbags are respectively disposed between the plurality of elastic keels; and A plurality of air guide tubes are connected to the plurality of cylindrical air bags.

5. The posterior scleral macular pressure adjustment bracket according to claim 3, characterized in that: The flexible substrate further comprises: an escape portion, wherein the escape portion is recessed from the middle of the arc-shaped surface of the flexible substrate toward the center of the circle of the flexible substrate to form an escape gap; and A plurality of stitching parts are respectively arranged on both sides of the flexible substrate and near the center of the circle.

6. The posterior scleral macular pressure adjustment bracket according to claim 1, characterized in that: The multiple air bags are arranged in a staggered manner.

7. The posterior scleral macular pressure adjustment bracket according to claim 1, characterized in that: The opening angle of the bracket body is greater than or equal to 50° and less than or equal to 60°.

8. The posterior scleral macular pressure adjustment bracket according to claim 1 or 3, characterized in that: Each of the airbags is hemispherical or cylindrical in the inflated state.

9. The posterior sclera macular area pressure adjustment bracket according to claim 8, characterized in that: The deflated diameter of each airbag is 1-3 mm, and the height when inflated to be fully expanded is less than or equal to 5 mm.

10. The posterior sclera macular area pressure adjustment bracket according to claim 8, characterized in that: A plurality of gas volume indicating color rings are sequentially arranged on the circumferential side of each air bag from outside to inside, and the colors of the plurality of gas volume indicating color rings are different.

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