An implant for treating pathological myopic post-scleral bulging

Abstract

The present application belongs to the technical field of pathological myopia treatment, and particularly relates to an implant for treating pathological myopia post-scleral staphyloma. The implant comprises a core part, the side surface of the core part is provided with a first foot, a second foot and a third foot, at least one of the first foot, the second foot and the third foot is internally provided with a receiving end for receiving ultrasound and converting the ultrasound into electric energy; a micropump cavity is arranged in the core part, an electrolyte aqueous solution and an electrolysis device are arranged in the micropump cavity, a film is arranged on the upper surface of the micropump cavity, and the receiving end and the electrolysis device are in communication. The implant and the corresponding surgical method thereof improve the accuracy and controllability of the surgery, reduce the difficulty and risk of the surgery, and reduce the possibility of surgical inflammation and complications, and have a good application prospect.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of pathological myopia treatment, and particularly relates to an implant for treating posterior scleral staphyloma of pathological myopia. BACKGROUND

[0002] Pathological myopia is one of the main causes of blindness worldwide. It is an important and vision-threatening disease that can cause scleral thinning, axial elongation, localized posterior scleral expansion, and ultimately many serious complications, such as retinal detachment, myopic choroidal neovascularization, macular foveoschisis and macular hole, and choroidal atrophy. In order to control the progression of myopia, posterior scleral reinforcement surgery was first described by Shevelev in 1930 and modified to the Snyder-Thompson method in 1972, which is the most common surgery at present. By inserting the inferior oblique muscle without suturing the posterior pole, the graft is fixed in the macular area, and the two ends of the graft are sutured to the superior and inferior nasal quadrants. In 1961, Cottting described the X-type surgery, which uses a cruciform fascial graft extending from the four quadrants of the eyeball. The cruciform graft aims to support a larger area of the posterior pole without inserting between any muscle or tendon. However, due to the poor long-term effect, the therapeutic effect of the X-type surgery is questionable, and there are serious complications such as obstruction of the ciliary retinal artery, compression of the optic nerve and subsequent optic atrophy. Some modifications have been made to the single wide strip posterior scleral reinforcement. A wider graft is used to support the posterior pole, with a central portion of 10 to 12 mm in width. In order to support the scleral staphyloma of the posterior pole, an additional 8x8mm 2 A scleral band is placed between the graft and the eyeball to support the macular area. The two ends of a shuttle-shaped implant are fixed in the superiotemporal and inferior nasal to form a U-shaped scleral buckle.

[0003] In posterior scleral reinforcement surgery, the axial top pressure distance of the posterior scleral staphyloma is related to the correction degree of the surgery, so this distance is an important parameter in the surgery. However, the current implants are difficult to accurately adjust the axial top pressure distance of the posterior scleral staphyloma during the surgery. So far, the research on posterior scleral reinforcement surgery has only stopped at the change of the size of the implant, and there is still a lack of relevant research and innovation on the precise control and adjustment of the shape of the posterior scleral staphyloma. SUMMARY

[0004] In view of the problems of the prior art, the main purpose of the present application is to provide an implant for treating posterior scleral staphyloma of pathological myopia and a corresponding surgical method thereof, thereby reducing the difficulty of the surgery and improving the accuracy of the surgery.

[0005] An implant for treating pathological myopic posterior scleral staphyloma, comprising: a core portion, a first leg, a second leg, and a third leg disposed on the side of the core portion, at least one of the first leg, the second leg, and the third leg being internally provided with a receiving end for receiving ultrasound and converting the ultrasound into electrical energy;

[0006] A micropump cavity is provided in the core portion, an electrolyte aqueous solution and an electrolysis device are provided in the micropump cavity, a film is provided on the upper surface of the micropump cavity, and the receiving end is connected to the electrolysis device.

[0007] Preferably, the receiving end includes a PZT and a rectifier bridge for converting alternating current into direct current.

[0008] Preferably, at least one of the first pin, the second pin and the third pin is provided with an electrolysis indicator light, and the electrolysis indicator light is connected to the receiving end.

[0009] Preferably, the electrolysis indicator light is a red μ-LED.

[0010] Preferably, at least one position indicator light is provided in the core portion, and the position indicator light is connected to the receiving end.

[0011] Preferably, the position indicator light is a red μ-LED.

[0012] Preferably, the number of the position indicator lights is at least two, and the position indicator lights are symmetrically arranged on the edge of the core portion.

[0013] Preferably, the core portion is in the shape of a column with a horseshoe-shaped cross section.

[0014] Preferably, the first leg, the second leg and the third leg have the same shape, and are symmetrically arranged on the side of the core part.

[0015] Preferably, the aqueous electrolyte solution is a sodium hydroxide solution.

[0016] This invention introduces a novel treatment system for posterior scleral reinforcement surgery—wireless energy transmission technology. This technology shifts the surgical procedure from in vivo to in vitro, significantly reducing the surgical difficulty. Furthermore, the degree of staphyloma compression can be controlled in real time in vitro, with resolution down to the micron level. This improves the precision of axial scleral compression. Treatment can also be personalized and dynamic based on the degree of myopia and scleral condition, enhancing both efficacy and safety.

[0017] Obviously, based on the above contents of the present invention, according to common technical knowledge and customary means in this field, without departing from the above basic technical ideas of the present invention, other various forms of modifications, replacements or changes can be made.

[0018] The following further describes the above content of the present invention in detail through specific embodiments in the form of examples. However, this should not be construed as limiting the scope of the above subject matter of the present invention to the following examples. All technologies implemented based on the above content of the present invention fall within the scope of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 is a top view of the implant of the present invention;

[0020] Figure 2 is a side view of an implant of the present invention;

[0021] Figure 3 This is a schematic diagram of the implant of the present invention being integrated with the eyeball after being implanted into the sclera;

[0022] Figure 4 The results of surgical treatment of posterior scleral staphyloma in animals in Experimental Example 1 are shown.

[0023] Among them, 1-first leg, 2-second leg, 3-third leg, 4-core, 5-electrolysis indicator light, 6-eyeball, 7-optic nerve. DETAILED DESCRIPTION

[0024] Example 1 Implant for treating pathological myopic posterior scleral staphyloma

[0025] The implant structure of this embodiment is as follows Figure 1 、 2 As shown, it includes: a core part 4, and a first leg 1, a second leg 2 and a third leg 3 are arranged on the side of the core part 4. The first leg 1, the second leg 2 and the third leg 3 have the same shape, and the first leg 1, the second leg 2 and the third leg 3 are symmetrically arranged on the side of the core part 4.

[0026] The first leg 1 is provided with a receiving terminal for receiving ultrasound and converting it into electrical energy. The receiving terminal includes a PZT (a cylindrical piece with a specification of 3*1mm) and a rectifier bridge for converting AC power into DC power. Two position indicators are symmetrically provided on the edge of the core 4. The position indicators are red μ-LEDs. The position indicators are powered by the receiving terminal in the first leg 1. During surgery, when the PZT at the receiving terminal in the first leg 1 receives ultrasound, the two position indicators light up to confirm the appropriate implant position.

[0027] The second leg 2 is provided with a receiving terminal for receiving ultrasound and converting it into electrical energy. The receiving terminal comprises a PZT (a cylindrical piece with a size of 3*1mm) and a rectifier bridge for converting AC power into DC power. The core 4 houses a micropump cavity, which contains an aqueous electrolyte solution and an electrolysis device. The electrolysis device comprises gold / copper interdigitated electrodes, and is powered by the receiving terminal in the second leg 2. In this embodiment, the aqueous electrolyte solution is sodium hydroxide solution. A thin film is provided on the upper surface of the micropump cavity. The second leg 2 is also provided with an electrolysis indicator 5, which is powered by the receiving terminal in the second leg 2. The electrolysis indicator 5 is a red μ-LED. When the PZT at the receiving terminal in the second leg 2 receives ultrasound, the red μ-LED at the electrolysis indicator 5 illuminates, indicating the start of electrolysis. Over time, the amount of gas generated by electrolysis increases, the gas pressure rises, and the height of the bulging film in the micropump cavity increases.

[0028] The core part 4 is shaped like a column with a horseshoe-shaped cross section. The horseshoe-shaped notch is used to allow the optic nerve 7 to pass through. The first leg 1, the second leg 2 and the third leg 3 are used to be sutured to the sclera. After the implant of this embodiment is implanted into the eyeball 6, the combination of the implant and the eyeball 6 is as follows: Figure 3 shown.

[0029] By controlling the timing of ultrasound, the duration of electrolysis, and thus the amount of gas generated, can be precisely controlled. This allows precise control of the diaphragm bulge height of the micropump cavity during surgery, thereby achieving precise control of the pressure height of the staphylococcal tumor. The control accuracy of the implant pressure height in this embodiment can reach the micron level.

[0030] When the implant of this embodiment is implanted, the process is as follows:

[0031] Prepare an ultrasound transmitter and the implant of this embodiment. The ultrasound transmitter consists of an ultrasound circuit board and a PZT probe for excitation, modulated at a frequency of 680 kHz. The receiving end of the implant is a 3 x 1 mm PZT cylindrical disc with the same resonant frequency. The specific surgical procedure is as follows: Preoperatively, the patient's intraocular pressure, eye axis, and fundus are tested, and the eyelids are opened with a lid speculum. A 360° circular conjunctival incision is performed on the experimental eye, and the extraocular and rectus muscles are separated to fully expose the diseased sclera at the posterior pole of the eye. The implant is implanted into the sclera at the posterior pole of the eye, with the center of core 4 corresponding to the site of the staphyloma lesion and the gap in core 4 clear of the optic nerve. Ultrasound is used to initiate an electrochemical reaction in the micropump cavity, specifically H2O → H2 + O2. The generated gas remains in the sealed micropump cavity. Due to the cavity's tightness, the gas gradually accumulates over time, causing the pressure within the cavity to increase, resulting in a bulging of the film on the upper surface of the micropump cavity. The upper surface film corresponds to the treatment of staphyloma, and the height of the film bulge is the thickness of the staphyloma. The height of the film bulge can be controlled by the duration of external ultrasound application.

[0032] The technical solution of the present invention is further illustrated by experiments below.

[0033] Experimental Example 1: Animal Experiment on Treatment of Posterior Scleral Staphyloma

[0034] 1. Experimental Methods

[0035] The implant structure and surgical method used in this experimental example were the same as those in Example 1. Three rabbits were used for the experiment, and varying degrees of axial length adjustment were achieved through timed manipulation. The animals were housed for one week prior to surgery. Antibiotic eye ointment was used to prevent infection during postoperative recovery. Body weight and temperature were recorded daily, and general condition was observed. Changes in axial length and diopter were measured preoperatively and postoperatively using an IOLmaster and an A / B-type ophthalmic ultrasound system.

[0036] 2. Experimental Results

[0037] The treatment distance is the change in the length of the rabbit eye axis before and after surgical treatment. By controlling the length of time, different treatment distances and correction degrees can be achieved. Figure 4 As shown in the table below, the treatment distances of the three rabbits were 200 μm, 1000 μm, and 750 μm, respectively, indicating that the implant and surgical method of the present invention can precisely control the treatment distance at the micron level, thereby precisely controlling the correction degree.

[0038] Rabbit 1 Rabbit 2 Rabbit 3 Treatment distance 200um 1000um 750um Correction degree 60 300 225

[0039] As can be seen from the above embodiments and experimental examples, the implant of the present invention and its corresponding surgical method improve the precision and controllability of surgery, while reducing the difficulty and risk of surgery and the possibility of surgical inflammation and complications. Therefore, the present invention has a good application prospect.

Claims

1. An implant for treating pathological myopic posterior scleral staphyloma, characterized in that: include: A core part (4), wherein a first leg (1), a second leg (2) and a third leg (3) are provided on a side surface of the core part (4), and at least one of the first leg (1), the second leg (2) and the third leg (3) is provided with a receiving end for receiving ultrasound and converting the ultrasound into electrical energy; A micropump cavity is provided in the core part (4), an electrolyte aqueous solution and an electrolysis device are provided in the micropump cavity, a thin film is provided on the upper surface of the micropump cavity, and the receiving end is connected to the electrolysis device; When the implant is implanted: Ultrasound causes an electrochemical reaction to begin in the micropump cavity, and the generated gas exists in the sealed micropump cavity. Due to the sealing of the cavity, the amount of gas gradually accumulates over time, causing the pressure in the cavity to increase, so that the film on the upper surface of the micropump cavity bulges; the height of the film bulge is the thickness of the staphylococcal bulge; the height of the film bulge is controlled by the time of external ultrasound application.

2. The implant according to claim 1, characterized in that: The receiving end includes a PZT and a rectifier bridge for converting alternating current into direct current.

3. The implant according to claim 1, wherein: At least one of the first pin (1), the second pin (2) and the third pin (3) is provided with an electrolysis indicator light (5), and the electrolysis indicator light (5) is connected to the receiving end.

4. The implant according to claim 3, characterized in that: The electrolysis indicator light (5) is a red μ-LED.

5. The implant according to claim 1, wherein: At least one position indicator light is provided in the core part (4), and the position indicator light is connected to the receiving end.

6. The implant according to claim 5, characterized in that: The position indicator light is a red μ-LED.

7. The implant according to claim 5, characterized in that: The number of the position indicator lights is at least two, and the position indicator lights are symmetrically arranged on the edge of the core part (4).

8. The implant according to claim 1, characterized in that: The core part (4) is in the shape of a column with a horseshoe-shaped cross section.

9. The implant according to claim 1, characterized in that: The first leg (1), the second leg (2) and the third leg (3) have the same shape, and the first leg (1), the second leg (2) and the third leg (3) are symmetrically arranged on the side of the core part (4).

10. The implant according to claim 1, characterized in that: The electrolyte aqueous solution is a sodium hydroxide solution.

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