Sensor support and intraocular pressure measurement drainage device

Abstract

The invention relates to the technical field of medical instruments, in particular to a sensor support and an intraocular pressure measurement drainage device.The sensor support comprises a support body, a sensor mounting structure and a drainage device mounting structure, and the sensor mounting structure and the drainage device mounting structure are arranged on the support body; the support body is of a plate-shaped structure. The intratonometer and an MIGS instrument are integrated, the core is to break through a'treatment-monitoring 'closed loop of glaucoma, and the clinical pain point that postoperative intraocular pressure fluctuation cannot be perceived in real time and the reexamination compliance of a patient is low is solved; compared with an independent MIGS instrument in the market, the integrated equipment continuously monitors intraocular pressure and wirelessly transmits data through the implantable sensor, so that a doctor can accurately evaluate an MIGS postoperative effect, find an intraocular pressure peak value or instrument failure in an early stage, formulate a personalized treatment scheme, avoid optic nerve injury, reduce the burden of a patient frequently going to a hospital for reexamination, and improve the patient experience. The crossing from a single operation to long-term chronic disease digital management is realized, and the curative effect and the life quality of a patient are remarkably improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a sensor support and an intraocular pressure measuring and draining device. BACKGROUND

[0002] Glaucoma is one of the three major causes of blindness in human eyes and is extremely harmful. High intraocular pressure is considered an important risk factor for the onset of glaucoma. Therefore, intraocular pressure is an important indicator for determining the treatment target of glaucoma and evaluating the treatment effect and prognosis in clinical practice.

[0003] At present, the treatment of glaucoma is to determine the treatment plan according to the test results after detecting the intraocular pressure, visual acuity and fundus condition of the patient. Intraocular pressure is one of the key diagnostic criteria for glaucoma and an important basis for determining whether the subsequent treatment is effective.

[0004] The intraocular pressure meter that has been put on the market is mainly indirect measurement. The intraocular pressure value is obtained by measuring the deformation of the cornea and then using the relationship between the corneal deformation and the intraocular pressure. However, this indirect measurement based on the deformation of the cornea has specific requirements for the thickness and curvature of the cornea, and is not suitable for some patients. Moreover, this intraocular pressure meter is a single-point measurement, which cannot monitor the intraocular pressure in real time and continuously, so it cannot reflect the changes in the intraocular pressure of the patient. The preferred practice pattern guidelines of the American Academy of Ophthalmology (AAO) and the American Glaucoma Society (AGS) also suggest that doctors should develop treatment decisions based on a series of intraocular pressure measurements, rather than a single data point, and in some cases even based on day-night assessment. Therefore, based on the current situation of glaucoma disease and the needs of disease diagnosis and treatment of the population, it is urgent to develop an intraocular pressure monitoring device that can meet the needs of real-time, continuous and normal patient self-management for the clinical management of glaucoma. SUMMARY

[0005] In order to solve the problem that the intraocular pressure cannot be monitored in real time and continuously in the prior art, the present application provides a sensor support. Through reasonable structural design, the sensor support can simultaneously realize the installation and fixation of the sensor and the drainage tube, thereby realizing the integrated setting of the intraocular pressure detection and the aqueous humor drainage function. The intraocular pressure detection and the aqueous humor drainage can be realized by one implantation, and the intraocular pressure can be continuously monitored, thereby solving the problem that the intraocular pressure cannot be monitored in real time and continuously in the prior art.

[0006] The technical solution adopted by the present application to solve the technical problems is: A sensor support, comprising a support body, a sensor mounting structure and a drainage device mounting structure arranged on the support body; the support body is a plate-shaped structure.

[0007] Optionally, the support body comprises a first end and a second end connected to each other; the sensor mounting structure is arranged at the first end; the width of the first end is greater than the width of the second end.

[0008] Optionally, the second end is an arc-shaped plate.

[0009] Optionally, the sensor mounting structure is a first slot-shaped structure.

[0010] Optionally, the drainage device mounting structure is a second slot-shaped structure distributed along the length direction of the support body.

[0011] Optionally, the second slot-shaped structure and the sensor mounting structure are arranged on the same side of the support body, and the second slot-shaped structure and the sensor mounting structure are communicated.

[0012] Optionally, the second slot-shaped structure and the sensor mounting structure are arranged on two sides of the support body, respectively.

[0013] Optionally, the drainage device mounting structure is a through hole distributed along the length direction of the support body.

[0014] Optionally, the drainage device mounting structure comprises a drainage structure mounting slot and a drainage hole communicated with the drainage structure mounting slot.

[0015] Another object of the present application is to provide an intraocular pressure measuring drainage device comprising the sensor support as described above, and an intraocular pressure sensor and a drainage device mounted on the sensor support.

[0016] The beneficial effects of the present application are: The sensor support provided by the present application integrates the tonometer and the minimally invasive glaucoma surgery instrument (MIGS instrument) into one, and the core is to break the glaucoma "treatment-monitoring" closed loop, solve the clinical pain points that the postoperative intraocular pressure fluctuation cannot be perceived in real time and the patient's review compliance is low; compared with the independent MIGS instrument on the market, the integrated device continuously monitors the intraocular pressure through the implantable sensor and wirelessly transmits the data, so that the doctor can accurately evaluate the postoperative effect of MIGS, early detect the peak value of intraocular pressure or the failure of the instrument, develop a personalized treatment plan, avoid optic nerve damage, and at the same time reduce the patient's frequent hospital review burden, realize the leap from single surgery to long-term digital management of chronic diseases, and significantly improve the curative effect and the patient's quality of life. BRIEF DESCRIPTION OF DRAWINGS

[0017] The present application will be further described below in combination with the drawings and examples.

[0018] Figure 1 is the structure of the sensor support in the present application Figure 1 ; Figure 2 is a structure diagram of a sensor support in the present application Figure 2 ; Figure 3 is a structure diagram of a sensor support in the present application Figure 3 ; Figure 4 is a structure diagram of a sensor support in the present application Figure 4 ; Figure 5 is a structure diagram of a sensor support in the present application Figure 5 ; Figure 6 is a partial enlarged view of A in the present application Figure 5 ; Figure 7 is an assembly diagram of a sensor support and a drainage tube in the present application.

[0019] In the figure: 1 - support body; 11 - first end; 12 - second end; 2 - sensor mounting structure; 3 - drainage device mounting structure; 31 - drainage structure mounting groove; 32 - drainage hole; 33 - limiting hole; 4 - drainage tube. DETAILED DESCRIPTION

[0020] The present application will now be further described in detail. The examples described below are exemplary and are intended to explain the present application, and cannot be understood as a limitation of the present application, all other examples obtained by those skilled in the art based on the examples of the present application without creative labor belong to the scope of protection of the present application.

[0021] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the specific embodiments of the present application will be described in detail below with reference to the accompanying drawings.

[0022] The existing implantable intraocular pressure sensor is usually prepared based on a rigid MEMS process such as silicon-based, and the implantable drainage device such as drainage tube usually adopts a flexible material such as hydrogel polymer for biocompatibility and flexibility; because the implantable intraocular pressure sensor and the implantable drainage tube have completely different requirements for the material, it is difficult to realize the integrated design of the two, therefore, the existing intraocular pressure detection device does not have the drainage function, which leads to the existing intraocular pressure detection process and the aqueous humor drainage process needing to be implanted respectively to realize, the process is complicated.

[0023] In order to solve the problem that the intraocular pressure detection process and the aqueous humor drainage process need to be implanted respectively to realize in the prior art, the present application provides a sensor support, see Figures 1-6As shown, the sensor support includes a support body 1, and a sensor mounting structure 2 and a drainage device mounting structure 3 arranged on the support body 1; the sensor mounting structure 2 is used for mounting an intraocular pressure sensor, and the specific structure and size of the sensor mounting structure 2 are determined according to the required intraocular pressure sensor; the drainage device mounting structure 3 is used for mounting a drainage device, and the specific structure and size of the drainage device mounting structure 3 are determined according to the required drainage device; the sensor support can simultaneously mount the intraocular pressure sensor and the drainage device; during use, after the corresponding intraocular pressure sensor and drainage device are mounted, the sensor support can be implanted; in order to avoid the movement of the intraocular pressure sensor during detection, the support body 1 is preferably a plate-shaped structure, which on the one hand increases the contact area of the support body 1 and the inside of the eye, and reduces the risk of movement; on the other hand, the plate-shaped support body 1 is designed to be bent according to the curvature of the eyeball, so as to ensure that the plate-shaped structure is tightly attached to the eyeball after implantation, so that the plate-shaped structure can be "adsorbed" on the eyeball, thereby avoiding the movement of the intraocular pressure sensor, and ensuring the accuracy and stability of the intraocular pressure detection process.

[0024] The support body 1 is designed as a plate-shaped structure, which is convenient for miniaturization design and suitable for implantation in the ocular microenvironment, and provides a shared bearing platform for the intraocular pressure sensor and the drainage device, thereby realizing functional integration. By integrating the two functional structures on the same support body 1, the number of components can be reduced, the assembly complexity can be reduced, and the consistency and reliability of the overall structure can be improved.

[0025] The material of the support body 1 in the present application can be titanium alloy or other materials suitable for medical implantation.

[0026] The sensor support provided by the present application integrates the tonometer and the minimally invasive glaucoma surgery instrument (MIGS instrument) in one, and the core is to break through the glaucoma "treatment-monitoring" closed loop, solve the clinical pain points that the postoperative intraocular pressure fluctuation cannot be perceived in real time and the patient's review compliance is low; compared with the independent MIGS instrument on the market, the integrated device continuously monitors the intraocular pressure through the implantable sensor and wirelessly transmits the data, so that the doctor can accurately evaluate the postoperative effect of MIGS, early detect the peak value of intraocular pressure or the failure of the instrument, develop a personalized treatment plan, avoid optic nerve damage, and at the same time reduce the burden of frequent hospital review of patients, realize the leap from single surgery to long-term digital management of chronic diseases, and significantly improve the curative effect and the quality of life of patients.

[0027] In addition, the present application simultaneously mounts the intraocular pressure sensor and the drainage device, so as to realize the integrated setting of the intraocular pressure detection and the aqueous humor drainage function, and realize the intraocular pressure detection and the aqueous humor drainage through one implantation, without increasing the implantation times, without increasing the iatrogenic injury, and without increasing the pain of patients, so as to realize the direct anterior chamber intraocular pressure detection and the aqueous humor drainage.

[0028] Specifically, after the sensor support is implanted with the integrated intraocular pressure sensor and the sensor support of the drainage device, the treatment function of aqueous humor drainage can be realized; the intraocular pressure sensor measures the intraocular pressure at the same time to confirm the treatment effect and determine whether the treatment plan needs to be adjusted.

[0029] The intraocular pressure sensor and the drainage device in the application can be selected from existing technologies; specifically, the application preferably has a Fabry-Perot microcavity on the intraocular pressure sensor, and in use, the outer surface of the Fabry-Perot microcavity is in contact with the intraocular fluid to sense the change in intraocular pressure; when the intraocular pressure rises, the Fabry-Perot microcavity deforms, causing the optical path of the reflected light to change, the interference pattern to change, and the spacing between the interference fringes to change; by accurately identifying, segmenting, and extracting the interference fringe region contained in the interference pattern, binarizing the extracted fringe skeleton, identifying the order of each fringe, and then calculating the center deflection of the Fabry-Perot microcavity membrane after being pressed, the pressure value of the Fabry-Perot microcavity membrane calibrated by the calibration device is one-to-one corresponding, realizing the conversion of the photographed photo containing the interference fringe image into a pressure value, and then the intraocular pressure can be obtained according to the change of the interference pattern; based on the change of the sensor interference fringe spacing caused by the change of the intraocular pressure, the function relationship between the deflection of the Fabry-Perot microcavity in the center region of the sensor and the intraocular pressure can be established, and through the advanced M-net neural network training and sparse attention Transformer image repair algorithm integrated in the mobile phone APP, the sensor interference fringe region is automatically focused, identified, and cut, and real-time intraocular pressure demodulation is performed, realizing the patient's home mobile phone self-test of intraocular pressure, not relying on electromagnetic energy supply signal transmission, effectively avoiding signal loss caused by external factors.

[0030] The drainage device in the application can be any existing drainage device, for example, the drainage device can be a drainage tube 4, and further, the drainage tube 4 capable of adjusting and controlling the drainage efficiency is preferred, so as to control the drainage process according to the detection result of the intraocular pressure sensor.

[0031] The application further preferably has a gradually expanding diameter structure of the drainage channel of the drainage tube 4, so as to provide a directional drainage effect by introducing a gradually expanding diameter structure of the drainage channel during use, thereby improving the drainage efficiency.

[0032] Specifically, the drainage tube 4 preferably comprises a drainage tube body and a drainage channel arranged in the drainage tube body; to improve the drainage efficiency, the drainage channel is preferably of a gradually expanding diameter structure; the gradually expanding diameter structure in the present application specifically refers to that the inner diameters of the two ends of the drainage channel are different, and the inner diameters are gradually expanding structures. After the drainage tube is implanted, the aqueous humor is drained to the filtering tissue through the drainage channel; since the drainage channel is of a gradually expanding diameter structure, a directional drainage effect can be provided during use, and as the diameter of the pipeline increases, the flow rate decreases and the pressure increases, so that the aqueous humor is discharged to the subconjunctival space at a faster rate, thus having a higher initial drainage efficiency; on the contrary, the pressure decreases and the flow rate increases, and since the intraocular pressure is relatively high, the generation of backflow can be prevented.

[0033] Further, to ensure the drainage effect, the present application further preferably has that the diameter of the large-diameter end of the drainage channel is 0.05mm-0.3mm, and the diameter of the small-diameter end is 0.03mm-0.15mm; the smaller the diameter of the pipeline, the lower the probability of low intraocular pressure, but the smaller the diameter of the pipeline, on the one hand, cell debris and blood clots are easy to cause obstruction of the pipeline, and on the other hand, the treatment effect and the drainage efficiency will be reduced; from the design point of view, for the prevention and treatment of low intraocular pressure, on the one hand, the inner diameter size should be carefully selected, and on the other hand, the occurrence of low intraocular pressure should be inhibited by reasonably selecting the shape of the lumen; from the gradually expanding diameter of the drainage channel, when the intraocular pressure is too low, the pressure difference between the anterior chamber and the filtering bleb decreases, which reduces the discharge rate; in addition, as the diameter of the gradually expanding diameter drainage channel increases, the flow rate decreases and the pressure tends to increase (the pressure along the equal-diameter tube is constant), and since the intraocular pressure itself is low, the trend of pressure increase will be inhibited, and compared with the equal-diameter pipeline, this inhibition will more easily prevent the occurrence of low intraocular pressure.

[0034] The specific size of the drainage tube in the present application can be determined according to the requirements; the present application preferably has that the outer diameter of the drainage tube is 0.1mm-0.6mm, and the axial length is 3-15mm.

[0035] Specifically, the present application preferably has that the stent body 1 comprises a first end 11 and a second end 12 connected; wherein the first end 11 is a sensing end, and the sensor mounting structure 2 is arranged on the first end 11; the size of the first end 11 is determined according to the size of the intraocular pressure sensor; to improve the comfort, the present application preferably has that the width of the first end 11 is greater than the width of the second end 12.

[0036] This design enables the first end 11 to provide a larger mounting area to stably accommodate the intraocular pressure sensor, and the second end 12 is narrower, which is beneficial to reducing the tissue occupation of the implanted area and improving the comfort and adaptability. The structure of the width transition also enhances the mechanical compliance of the stent body 1, making it more conformable to the curvature of the eyeball.

[0037] Since the eyeball has a certain arc, in order to improve the fitting degree of the support body 1 and the eyeball, so that the support body 1 after implantation is better "adsorbed", ensure the accuracy and stability of the intraocular pressure detection result, and improve the comfort of the patient, the second end 12 is preferably an arc-shaped structure, and the arc of the arc-shaped structure is determined according to the arc of the eyeball.

[0038] In addition, the arc-shaped structure also helps to guide the aqueous humor to flow along a predetermined path, preventing backflow or stagnation.

[0039] In order to facilitate the installation of the intraocular pressure sensor, the sensor installation structure 2 is preferably a groove-shaped structure, which is referred to as a first groove-shaped structure; the first groove-shaped structure is preferably a square groove-shaped structure; the groove-shaped structure can limit and fix the intraocular pressure sensor, preventing displacement or falling during use, and ensuring that the sensing element is always in the best measurement position. The groove depth and width are accurately designed according to the shape of the intraocular pressure sensor to achieve a tight fit or interference fit, ensuring the continuity and accuracy of signal acquisition.

[0040] In order to facilitate the installation of the drainage device, as shown in Figures 1-3 , the drainage device installation structure 3 is preferably a groove-shaped structure distributed along the length direction of the support body 1, which is referred to as a second groove-shaped structure, and the installation and fixation of the drainage tube are achieved by embedding the drainage tube into the second groove-shaped structure.

[0041] One of the embodiments is that, as shown in Figure 1 , the second groove-shaped structure and the sensor installation structure 2 are arranged on the same side of the support body 1, and the second groove-shaped structure and the sensor installation structure 2 are communicated.

[0042] In order to consider the convenience of assembly and the stability of the drainage device, in the preferred embodiment, a limiting hole 33 is arranged at one end of the second groove-shaped structure away from the sensor installation structure 2.

[0043] As shown in Figure 7 , taking the drainage tube 4 as an example, after installing the drainage tube 4 in the second groove-shaped structure, the limiting hole 33 prevents the drainage tube 4 from falling off through the limiting action.

[0044] Specifically, the inner diameter of the limiting hole 33 is preferably a circular arc, and the inner diameter of the circular ring is preferably determined according to the outer diameter of the drainage tube 4, so that after installing the drainage tube 4 in the second groove-shaped structure, the limiting hole 33 realizes the fixation of the drainage tube 4 through interference fit, preventing the drainage tube 4 from falling off.

[0045] Another embodiment of the present application is that, as shown in Figure 2 , Figure 3As shown, the second groove-shaped structure and the sensor mounting structure 2 are arranged on both sides of the support body 1, so as to reduce the influence of the drainage process on the intraocular pressure detection process, improve the accuracy and stability of the detection result.

[0046] Another embodiment of the present application is that, referring to Figure 4 As shown, the drainage device mounting structure 3 is a through hole distributed along the length direction of the support body 1, so as to improve the stability of the structure while ensuring the drainage effect.

[0047] For the case that the drainage device is not a drainage tube, referring to Figure 5 、 Figure 6 As shown, another embodiment of the present application is that the drainage device mounting structure 3 includes a drainage structure mounting groove 31 and a drainage hole 32 communicating with the drainage structure mounting groove 31; wherein the drainage structure mounting groove 31 is adapted to mount the drainage device, and the drainage hole 32 communicating with the drainage structure mounting groove 31 is an aqueous humor drainage channel.

[0048] Another object of the present application is to provide an intraocular pressure measurement drainage device, which comprises the sensor support as described above, and an intraocular pressure sensor and a drainage device mounted on the sensor support.

[0049] The intraocular pressure measurement drainage device provided by the present application can realize the integrated setting of the intraocular pressure detection and the aqueous humor drainage function by introducing a sensor support capable of simultaneously mounting the intraocular pressure sensor and the drainage device, so that the intraocular pressure detection and the aqueous humor drainage can be realized by one-time implantation, without increasing the number of implantations, without increasing the iatrogenic damage, and without increasing the pain of the patient.

[0050] The intraocular pressure measurement drainage device provided by the present application is suitable for primary open-angle glaucoma or patients with cataract; the intraocular pressure measurement drainage device is an implantable device, which can continuously measure the intraocular pressure and also consider the intraocular pressure control treatment; the measurement mode of the intraocular pressure sensor in the intraocular pressure measurement drainage device is preferably optical measurement, and the signal monitoring and transmission do not require energy supply; the intraocular pressure measurement drainage device is a portable device, which can meet the real-time measurement in various occasions such as work, travel and home; and the patient can use the doctor-patient interactive App as an ophthalmologist in his pocket.

[0051] Based on the above ideal embodiments according to the present application, through the above description, relevant personnel can make various changes and modifications without deviating from the technical idea of the present application. The technical scope of the present application is not limited to the contents in the specification, and must be determined by the scope of claims.

Claims

1. A sensor bracket, characterized in that, It includes a support body (1), and a sensor mounting structure (2) and a drainage device mounting structure (3) disposed on the support body (1); the support body (1) is a plate-shaped structure.

2. The sensor bracket as described in claim 1, characterized in that, The bracket body (1) includes a first end (11) and a second end (12) connected together; the sensor mounting structure (2) is disposed on the first end (11); the width of the first end (11) is greater than the width of the second end (12).

3. The sensor bracket as described in claim 2, characterized in that, The second end (12) is an arc-shaped plate.

4. The sensor bracket as described in claim 1, characterized in that, The sensor mounting structure (2) is a first groove structure.

5. The sensor bracket as described in any one of claims 1-4, characterized in that, The drainage device installation structure (3) is a second groove-shaped structure distributed along the length direction of the support body (1).

6. The sensor bracket as described in claim 5, characterized in that, The second groove structure and the sensor mounting structure (2) are located on the same side of the bracket body (1), and the second groove structure is connected to the sensor mounting structure (2).

7. The sensor bracket as described in claim 5, characterized in that, The second groove structure and the sensor mounting structure (2) are respectively disposed on both sides of the bracket body (1).

8. The sensor bracket as described in any one of claims 1-4, characterized in that, The drainage device mounting structure (3) consists of through holes distributed along the length of the support body (1).

9. The sensor bracket as described in any one of claims 1-4, characterized in that, The drainage device mounting structure (3) includes a drainage structure mounting groove (31) and a drainage hole (32) communicating with the drainage structure mounting groove (31).

10. An intraocular pressure measurement and drainage device, characterized in that, It includes the sensor holder as described in any one of claims 1-9, and an intraocular pressure sensor and a drainage device mounted on the sensor holder.

Images