Simple pressure applying device for posterior sclera macular region

Abstract

The utility model relates to the field of medical treatment, in particular to a simple pressure applying device for a posterior sclera macular area, which comprises a flexible pipeline with ductility and a plurality of fixing parts axially arranged on the flexible pipeline; the size of the spherical part is slightly larger than the diameter of an inner cavity of the flexible pipeline, and the spherical part can be arranged in the flexible pipeline in a relative sliding mode. The device is simple in structure, small in folding size and capable of being easily fed into a posterior sclera area from the outer side of the orbital bone, the position of a macular area pressure applying structure, namely the spherical piece, can be independently adjusted, the spherical piece does not need to extend into the orbital bone to be adjusted, surgical operation can be greatly simplified, and surgical risks are reduced.

Description

Technical Field

[0001] The utility model relates to the medical field, in particular to a simple pressure-applying device for the posterior sclera macular area. Background Art

[0002] Myopia is a serious problem among adolescents in my country. In 2018, the national youth myopia rate was 53.6%, and it continues to increase annually. Most modern medical science considers high myopia to be the result of a combination of genetics and the environment. One general description of the pathological process of myopia is that the axial growth of the eyeball causes it to change from a spherical shape to an ellipsoidal shape, but the vitreous humor, retina, and optic nerve within the eyeball cannot expand accordingly. This can lead to various eye diseases, such as arcus foveae, vitreous lesions, macular pigment abnormalities, optic disc tilt, retinal hemorrhages, lacquer cracks, choroidal atrophy, neovascularization, and visual field loss. Currently, applying pressure to the macular area of ​​the posterior sclera to inhibit this axial growth is an effective physical intervention.

[0003] However, since the macular area is located on the posterior sclera and is inconvenient to observe, traditional macular pressure application devices are difficult to successfully position in one go, resulting in the need to repeatedly adjust the position or posture of the device during the operation, and surgical tools need to be inserted into the orbital bone for operation and adjustment, which makes the surgical process more complicated during the adjustment process. Utility Model Content

[0004] In order to avoid adjustments made from outside the orbital bone and simplify surgical operations, the utility model proposes a simple pressure-applying device for the posterior scleral macular area, comprising: a flexible pipe, which is extensible and has multiple fixing parts arranged along the axial direction; a spherical piece, the size of which is slightly larger than the inner cavity diameter of the flexible pipe and can be relatively slidably arranged in the flexible pipe.

[0005] In one or more embodiments, the simple pressure-applying device for the posterior scleral macular area of ​​the present invention further includes an extension portion, which is arranged on one side of the flexible tube and fits at least partially with the flexible tube, and is located in the middle section of the flexible tube or extends in all directions along the axial direction of the flexible tube.

[0006] In one or more embodiments, the flexible pipe provided on one side of the extension portion is spirally arranged, and operating parts are extended from both ends of the spiral flexible pipe, and the inner cavity diameter of the operating part gradually increases with the extension length.

[0007] In one or more embodiments, there are multiple flexible pipes disposed on one side of the extension portion, and the multiple flexible pipes are cross-arranged.

[0008] In one or more embodiments, the extension portion includes: a circular shape, an elliptical shape, a triangular shape, a peach shape, a fan shape or a rectangular shape.

[0009] In one or more embodiments, an avoidance gap is further provided at the edge of the extension portion, and the avoidance gap is used to avoid the optic nerve near the macular area of ​​the posterior sclera.

[0010] In one or more embodiments, the edge or end of the extension portion is further provided with a fixing portion, and the fixing portion includes a sewing fixing area or an adhesive fixing area.

[0011] In one or more embodiments, a positioning protrusion is provided on the outer tube wall of the flexible pipe away from the extension portion, and a limiting groove is provided on the back side of the positioning protrusion.

[0012] In one or more embodiments, the simple pressure-applying device for the posterior scleral macular area of ​​the present invention further includes an air blowing member, which is detachably connected to the flexible tube and is used to blow gas into the flexible tube.

[0013] In one or more embodiments, the gas blowing member comprises an electric air pump or a syringe, wherein the outlet gas pressure of the electric air pump is adjustable.

[0014] The beneficial effects of the present invention include: the device of the present invention has a simple structure, a small folded volume, and is easy to deliver from the outside of the orbital bone to the posterior sclera area. The position of the spherical part, which is a pressure-applying structure for the macular area, can be adjusted independently without the need to probe into the orbital bone for adjustment, which can greatly simplify surgical operations and reduce surgical risks. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other embodiments can be obtained based on these drawings without paying any creative work.

[0016] Figure 1 This is a schematic structural diagram of a simple pressure-applying device for the posterior sclera macular area according to the first embodiment of the present invention;

[0017] Figure 2 This is a schematic structural diagram of a simple pressure-applying device for the posterior sclera macular area according to the second embodiment of the present invention;

[0018] Figure 3 This is a schematic structural diagram of a simple pressure-applying device for the posterior sclera macular area according to a third embodiment of the present invention;

[0019] Figure 4 This is a schematic structural diagram of a simple pressure-applying device for the posterior sclera macular area according to a fourth embodiment of the present invention;

[0020] Figure 5 Schematic diagram of a first connection method for fixing the flexible pipe and the extension portion in the second to fourth embodiments of the present invention;

[0021] Figure 6 Schematic diagram of the second connection method of the flexible pipe and the extension portion in the second to fourth embodiments of the present invention.

[0022] The meanings of the reference numerals in the above drawings are as follows: flexible pipe 10 , fixing portion 20 , spherical member 30 , extension portion 40 , avoidance notch 50 and positioning protrusion 60 . DETAILED DESCRIPTION

[0023] In order to make the purpose, technical solutions and advantages of the present invention more clearly understood, the embodiments of the present invention are further described in detail below in combination with specific embodiments and with reference to the accompanying drawings.

[0024] It should be noted that all expressions using "first" and "second" in the embodiments of the present invention are for the purpose of distinguishing two non-identical entities or non-identical parameters with the same name. It can be seen that "first" and "second" are only for the convenience of expression and should not be understood as limitations on the embodiments of the present invention. Subsequent embodiments will not explain this one by one.

[0025] In order to avoid the adjustment from outside the orbital bone and simplify the surgical operation, the present invention proposes an embodiment of a simple pressure-applying device for the posterior sclera macular area, such as Figure 1 As shown, it mainly consists of a flexible tube 10 and a spherical part 30 that can be inserted into the flexible tube, wherein the flexible tube 10 is long and ductile, and the flexible tube 10 is provided with multiple fixing parts 20 along the axial direction for suturing and fixing. The size of the spherical part 30 is slightly larger than the inner diameter of the flexible tube 10, and it can be relatively slidably arranged in the flexible tube 10 to achieve pressure on the macular area. This device can adjust the position of the spherical part 30 by blowing air into the flexible tube 10, avoiding the use of surgical tools to probe from outside the orbital bone for adjustment. This can greatly simplify the surgical operation. Based on this embodiment, there are also the following improvements:

[0026] In one embodiment, a plurality of fixing portions 20 are provided along the axial direction and can adopt adhesive fixing areas having an adhesive effect on biological tissue to achieve fixation between the flexible tube and the sclera.

[0027] In one embodiment, the plurality of fixing portions 20 provided along the axial direction may also be a plurality of protruding points protruding from the outer wall of the flexible tube, and the plurality of protruding points may be distributed continuously or spaced apart from each other, and each protruding point may be capable of being sutured and fixed to the biological tissue of the eye; or the protruding points may have hook-shaped, pointed fixing claws, including structures such as two claws, three claws, or multiple claws, which are inserted into the biological tissue of the eye through the fixing claws to achieve fixation between the flexible tube and the sclera.

[0028] In one embodiment, a positioning bump 60 is provided on the centerline of the outer surface of the flexible tube 10 where it contacts the sclera, and a limiting groove is provided on the back of the positioning bump. Specifically, this embodiment allows the pressing member to provide superimposed pressure on the edge of the macula when the pressing member rests above the positioning bump 60. Preferably, the protrusion height H of the positioning bump 60 is between [0.6 mm and 1 mm], which ensures the effectiveness of auxiliary force transmission and reduces discomfort to the patient's eyes. During use, the position of the positioning bump 60 can be adjusted by first adjusting the position of the flexible channel 10 so that it is located above the depression in the macula, while also raising the groove on the back to be located above the macula. Then, by injecting appropriate air pressure into the flexible tube 10, the spherical member 30 is moved. When the spherical member 30 moves above the positioning bump 60, it sinks into the positioning groove and stops moving, thus completing the positioning and pressure of the spherical member 30 on the macula. This embodiment helps reduce the adjustment time of the moving spherical member 30, thereby reducing discomfort during the adjustment process.

[0029] In an improved embodiment, the simplified posterior scleral macular pressure-applying device of the present invention further includes an extension portion, which is disposed on one side of the flexible tube and engages at least partially with the flexible tube. The extension portion is located in the middle of the flexible tube or extends axially along the flexible tube. The extension portion also includes an escape notch at its edge. The shape of the extension portion includes a quasi-circular, quasi-elliptical, quasi-triangular, quasi-peach-shaped, quasi-sector-shaped, or quasi-rectangular.

[0030] For details, see Figure 2In this embodiment, a rectangular extension portion 40 is further provided on one side of the flexible tube 10. The extension portion 40 can increase the contact area with the sclera, thereby playing an auxiliary fixation role. On the other hand, it can also play a primary fixation role by suturing and fixing the four corners A, B, C, and D to the sclera respectively or connecting the four corners in pairs to form a ring to be placed on the sclera and avoid the pupil. In addition, due to the addition of the extension portion, multiple flexible tubes 10 can be provided in this embodiment, such as the two independent flexible tubes 10 shown in this embodiment, and the two independent flexible tubes are arranged crosswise, allowing them to reach the macular area from different angles and paths, facilitating flexible selection during the operation, thereby further reducing the probability of needing to adjust the position of the flexible tube and the extension portion. In addition, the extension portion 40 in this embodiment extends in all directions along the axial direction of the flexible tube 10, and an avoidance gap 50 is provided at the edge of the extension portion. The avoidance gap 50 is used to avoid the optic nerve or pupil at the posterior sclera. During use, the extension part needs to be folded according to the alignment of AD and BC angles, and then the AD angle or BC angle is sent from the side of the orbital bone to the posterior sclera for unfolding, and the AD angle or BC angle is pulled out of the orbital bone from the other side, and then any of the four corners A, B, C, and D can be inserted with a top pressure piece, such as a small ball. After the small ball is in place, the four corners are sutured and fixed to the sclera respectively, or after the AD and BC corners are sutured to each other, the arc between AB and the arc between CD form a ring and are clamped on the sclera of the eyeball and fixed avoiding the pupil. Among them, the latter fixation method can reduce the difficulty of surgery and damage to the eyeball, and the arc between AD or BC is used to avoid the optic nerve.

[0031] In an optional embodiment, the fixing portions 20 at the four corners A, B, C, and D may also adopt adhesive fixing areas to achieve adhesion between the AD corner and the BC corner, or to achieve adhesive fixation between the four corners A, B, C, and D and the sclera.

[0032] In one embodiment, a positioning protrusion 60 is provided along the centerline of the flexible pipe 10 away from the extension 40, and a retaining groove is provided on the back of the positioning protrusion 60. This embodiment enables the pressing member 30 to assist in compression when it rests on the protrusion, while the retaining groove helps secure the pressing member 30.

[0033] In one embodiment, only one side surface of the extension portion may be provided with a flexible tube, and the extension portion only needs to be provided in the middle section of the flexible tube to reduce the overall volume of the device and facilitate deployment. Furthermore, since there are fewer fixing points, surgical fixation is more convenient.

[0034] For details, see Figure 3In this embodiment, an elliptical or peach-shaped extension 40 is provided on one side of the flexible tube 10. The extension 40 is generally S-shaped. The extension 40 can increase the contact area with the sclera, thereby providing auxiliary fixation. Furthermore, by suturing the ends E and F to the sclera or connecting the ends EF, a single-sided loop can be formed, which can be placed on the sclera and avoid the pupil, thereby providing primary fixation. Compared to the previous embodiment, this embodiment only has a single independent flexible tube 10. Its advantages are its small size and thin folded thickness, making it easier to deliver to the posterior sclera. Furthermore, the extension 40 requires almost no folding; only one end needs to be inserted from one side of the orbital bone and pulled out from the other end, making the surgical procedure simpler than the previous embodiment. A clearance notch 50 is also provided at the edge of the extension to avoid the optic nerve at the posterior sclera.

[0035] In an optional embodiment, the fixing portions 20 at the corners EF may also adopt adhesive fixing areas to achieve adhesion between the corners E and F, or to achieve adhesive fixation between the corners E and F and the sclera.

[0036] In one embodiment, a positioning protrusion (not shown) is provided along the centerline of the flexible pipe 10 away from the extension 40, and a retaining groove is provided on the back of the positioning protrusion. This embodiment enables the pressing member 30 to assist in compression when it rests on the protrusion, while the retaining groove helps secure the pressing member 30.

[0037] In one embodiment, one side surface of the extension portion can also be provided with only one flexible tube to increase the probability that the channel is located above the macular area. For example, the middle section of the flexible tube is spirally provided on the extension portion, and operating portions are extended from the openings at both ends of the flexible tube, and the inner cavity diameter of the operating portion gradually increases with the extension length.

[0038] For details, see Figure 4 In this embodiment, a quasi-elliptical extension 40 is provided on one side of the flexible tube 10. This extension primarily serves as a carrier for the flexible tube and secures it. It has four securing portions H, I, J, and K, each for securing it to the scleral suture. In this embodiment, because the flexible tube forms a large, disc-shaped area, it easily covers the area above the macula. This allows for minimal repositioning after delivery to the posterior sclera. Simply controlling the pressure member to stay directly above the macula is sufficient. Alternatively, the extension 40 in this embodiment can be quasi-circular, quasi-sector, or quasi-triangular. If the extension is triangular, a spiral-shaped flexible tube can be positioned at the center of the triangle, with securing portions 20 provided at each triangular location. During use, once the pressure member (not shown) has reached the area above the macula, the free end of the flexible tube, i.e., the operating portion, can be sheared off.

[0039] In an optional embodiment, the fixing parts 20 at the four corners of H, I, J, and K can also be replaced with adhesive parts to achieve adhesive fixation of the four corners of H, I, J, and K to the sclera.

[0040] In one embodiment, a positioning protrusion (not shown) is provided along the centerline of the flexible pipe 10 away from the extension 40, and a retaining groove is provided on the back of the positioning protrusion. This embodiment enables the pressing member 30 to assist in compression when it rests on the protrusion, while the retaining groove helps secure the pressing member 30.

[0041] In an optional embodiment, operating portions extend from the openings at both ends of the flexible tube. The operating portions are removably connected to the extension portion by inserting into notches provided on the extension portion, or the operating portions are removably connected to the extension portion via adhesive areas provided on the operating portions. This removable design facilitates storage and organization of the device.

[0042] In one embodiment, the flexible pipe and the extension portion can be fixed in the following manner: Figure 5 or Figure 6 As shown in , the advantages of the two fixing methods are: Figure 5 The cylindrical structure of the flexible pipe is maintained, which makes it easier for the top pressure piece to move in the flexible pipe cavity. Figure 6 Part of the lumen wall of the flexible tube is replaced by an extension portion, making the overall thickness of the device thinner and easier to deliver from the orbital bone side.

[0043] In one embodiment, the spherical member 30 can be replaced with an ellipsoidal pressure member. Specifically, in one optional embodiment, the diameter of the spherical member 30 is 1-3 mm. The diameter of the spherical member 30 is slightly larger than the inner diameter of the flexible tube in its natural state, so that the spherical member can remain stably in any position when placed in the cavity. In another optional embodiment, the spherical member 30 is designed to be ellipsoidal. The ellipsoidal shape is easier to insert from the orbital bone side and provides a larger pressure area to act on the macular area. The ellipsoidal shape has a thickness of 1-3 mm and a length of 3-5 mm. When using OCT imaging, its scattering surface is larger, making it easier to form a clear OCT image.

[0044] In one embodiment, the spherical member 30 , the extension portion 40 and the flexible tube 10 are all made of human tissue compatible materials to avoid immune rejection. Optional materials include medical silicone materials, PVC (polyvinyl chloride) materials and / or PE (polyethylene).

[0045] In one embodiment, the size of the pressing member can be adjusted according to actual conditions.

[0046] In one embodiment, the simplified posterior scleral macular pressure-applying device of the present invention further includes a gas-inflating member (not shown), which is detachably connected to the flexible tube 10 and is used to inject gas into the flexible tube 10. The gas-inflating member includes an electric air pump or a syringe, wherein the outlet gas pressure of the electric air pump is adjustable, thereby facilitating the use of the aforementioned embodiment of first positioning the positioning protrusion on the flexible tube and then positioning the spherical member 30.

[0047] In an optional embodiment, in each of the above-mentioned embodiments with an extension portion, the flexible tube 10 is made of medical silicone material, and the extension portion 40 is made of PVC (polyvinyl chloride) material or PE (polyethylene) material to provide a certain degree of support (slightly elastic or inelastic); the bonding area is formed of a biocompatible bonding material.

[0048] In a second aspect of the present invention, based on the simple pressure-applying device for the posterior sclera macular region described in the aforementioned embodiments, the present invention further provides a method for adjusting the position of a pressure member of the simple pressure-applying device for the posterior sclera macular region, the method comprising: step S1, folding the simple pressure-applying device, inserting it into the posterior sclera, and unfolding it, attaching a flexible tube to the posterior sclera, and maintaining the two ends of the flexible tube open to the outside of the orbital bone; step S2, inserting the pressure member into the flexible tube through either open end, and moving the pressure member by blowing air into the flexible tube using an air blowing member; step S3, observing the movement position of the pressure member in real time using OTC imaging, and stopping the blowing when the pressure member moves to above the macular region of the posterior sclera. The air blowing member comprises an electric air pump or a syringe, and the outlet gas pressure of the electric air pump is adjustable.

[0049] Specifically, OTC imaging, short for Optical Coherence Tomography (OCT), is a technology based on the principle of low-coherence interference of light. It acquires backscattered light from a sample and, through demodulation and processing of the interference signal, reconstructs a two-dimensional tomographic or three-dimensional structural image of the sample. During the OTC imaging positioning process, the macula is slightly concave compared to other areas of the posterior sclera, which can be used to locate the macula. Similarly, the positioning bumps on the top pressure piece or flexible tube will also cause the shape of the interface between the posterior sclera and the lens to change. By observing the positioning bumps on the top pressure piece or flexible tube, the OTC image can be indirectly used to locate the position of the positioning bumps on the top pressure piece or flexible tube. When the raised image formed by the top pressure piece (including a spherical or ellipsoidal top pressure piece) coincides with the position of the macula, the inflation is stopped. At this time, the top pressure piece stays directly above the macula, thereby achieving compression of the macula.

[0050] The solution of this embodiment is simple to operate and does not require the use of surgical tools to probe into the orbital bone to adjust the position of the pressing piece, thereby greatly simplifying the surgical operation process.

[0051] The above are exemplary embodiments disclosed herein, but it should be noted that various changes and modifications may be made without departing from the scope of the present invention as defined in the claims. The functions, steps, and / or actions of the method claims according to the disclosed embodiments described herein do not need to be performed in any particular order.

[0052] Those skilled in the art should understand that the discussion of any of the above embodiments is merely illustrative and is not intended to limit the scope of the disclosure of the present invention (including the claims) to these examples. Based on the principles of the present invention, the technical features of the above embodiments or different embodiments may be combined, and there are many other variations of the various aspects of the above embodiments, which are not provided in detail for the sake of clarity. Therefore, any omissions, modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A simple pressure-applying device for the posterior sclera macular area, characterized in that: include: A flexible pipe, wherein the flexible pipe has ductility and is provided with a plurality of fixing portions along the axial direction; The spherical part has a size slightly larger than the inner cavity diameter of the flexible pipe and can be relatively slidably arranged in the flexible pipe.

2. The simple pressure-applying device for the posterior sclera macular area according to claim 1, characterized in that: It also includes an extension portion, which is arranged on one side of the flexible pipe and fits at least partially with the flexible pipe, and is located in the middle section of the flexible pipe or extends in all directions along the axial direction of the flexible pipe.

3. The simple pressure-applying device for the posterior sclera macular area according to claim 2, characterized in that: The flexible pipe arranged on one side of the extension part is arranged in a spiral shape, and operating parts are extended from both ends of the spiral flexible pipe. The inner cavity diameter of the operating part gradually increases with the extension length.

4. The simple pressure-applying device for the posterior sclera macular area according to claim 2, characterized in that: There are multiple flexible pipes arranged on one side of the extension portion, and the multiple flexible pipes are cross-arranged.

5. The simple pressure-applying device for the posterior sclera macular area according to claim 3 or 4, characterized in that: The extension portion includes: a circular shape, an elliptical shape, a triangular shape, a peach shape, a fan shape or a rectangular shape.

6. The simple pressure-applying device for the posterior sclera macular area according to claim 5, characterized in that: An avoidance gap is also provided at the edge of the extension portion, and the avoidance gap is used to avoid the optic nerve near the macular area of ​​the posterior sclera.

7. The simple pressure-applying device for the posterior sclera macular area according to claim 6, characterized in that: The edge or end of the extension portion is further provided with a fixing portion, and the fixing portion includes a sewing fixing area or an adhesive fixing area.

8. The simple pressure-applying device for the posterior sclera macular area according to claim 2, characterized in that: A positioning convex point is provided on the outer tube wall of the flexible pipe away from the extension portion, and a limiting groove is provided on the back side of the positioning convex point.

9. The simple pressure-applying device for the posterior sclera macular area according to claim 1, characterized in that: Also includes: A gas blowing member is detachably connected to the flexible pipe and is used to blow gas into the flexible pipe.

10. The simple pressure-applying device for the posterior sclera macular area according to claim 9, characterized in that: The gas blowing member includes an electric air pump or a syringe, wherein the outlet gas pressure of the electric air pump is adjustable.

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