CN113069073A - Intraocular pressure measuring implant, terminal device and implanting method in human eyeball sclera - Google Patents
Intraocular pressure measuring implant, terminal device and implanting method in human eyeball sclera Download PDFInfo
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- CN113069073A CN113069073A CN202110239227.1A CN202110239227A CN113069073A CN 113069073 A CN113069073 A CN 113069073A CN 202110239227 A CN202110239227 A CN 202110239227A CN 113069073 A CN113069073 A CN 113069073A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B3/00—Apparatus for testing the eyes; Instruments for examining the eyes
- A61B3/10—Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions
- A61B3/16—Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions for measuring intraocular pressure, e.g. tonometers
Abstract
The invention is applicable to the technical field of ophthalmic medical equipment, and provides an intraocular pressure measurement implant in the sclera of a human eyeball, terminal equipment and an implantation method. The sclera valve or the pressure sensor is sutured by adopting the suture line with controllable tension to reconstruct the stress, the stress is transmitted to the pressure sensor, the pressure sensor can be calibrated by adjusting the tension on the suture line during the operation, so that the immediate measurement capability is established, the sclera tissue is gradually healed in the long term after the operation, and meanwhile, the suture line is degraded (if the degradable suture line is used), the sclera replaces the suture line to transmit the stress to the sensor, thereby ensuring the long-term usability.
Description
Technical Field
The invention belongs to the technical field of ophthalmic medical equipment, and particularly relates to an intraocular pressure measuring implant, terminal equipment and an implanting method in human eyeball sclera.
Background
Glaucoma is the first irreversible blinding eye disease worldwide. The number of primary glaucoma patients is over 600 million in 2020, and will exceed 1 hundred million in 2040. China is the country with the most glaucoma patients, and in 202 years, the number of glaucoma patients in China reaches 2100 ten thousand, and the number of blinding people reaches 567 ten thousand. With the accelerated aging process, the prevalence rate of glaucoma increases year by year, and the prevalence rate of primary glaucoma of people aged 40 years and older is 2.3% -3.6%. The clinical manifestations of glaucoma are mainly increased Intraocular pressure (IOP), which can lead to slow irreversible damage of the optic nerve, and in the early stage of glaucoma, the Intraocular pressure fluctuates and is unstable, and may be increased only for hours within a day, and is difficult to detect, so 54.9% -82% of glaucoma patients are not diagnosed. Therefore, real-time monitoring of intraocular pressure for 24 hours is important for timely finding the increase of intraocular pressure and guiding the diagnosis and prevention of glaucoma. Meanwhile, for severe glaucoma patients, the real-time knowledge of the intraocular pressure condition of the patients can also help ophthalmologists to set, follow-up and manage the target intraocular pressure of the glaucoma patients, and constantly optimize the treatment of glaucoma in-hospital and out-of-hospital.
At present, the intraocular pressure detection method mainly comprises a finger measurement method and an intraocular pressure measurement method, wherein the finger measurement method is rough and needs abundant clinical detection experience of inspectors, and the intraocular pressure measurement method is more intuitive and accurate, but has the limitation that professional knowledge is needed when in use. Therefore, the intraocular pressure device which is easy to operate, accurate in measurement and capable of monitoring in real time is urgent.
Currently, most of the widely used tonometers carry out diagnosis and control by measuring IOP, and the common measurement method is Goldmann applanation tonometery, which has the disadvantages that real-time monitoring cannot be carried out, and meanwhile, a deformation sensor is adopted to measure corneal deformation (the shape (curvature) of a cornea changes to a certain degree along with the intraocular pressure), and the mode has the problems that the combination of the sensor and the surface of the cornea is not firm and stable, the deformation transmission is not reliable, and the measurement result is inaccurate; can not be worn for a long time, and is easy to generate inflammatory reaction of cornea and conjunctiva.
Disclosure of Invention
The invention provides an intraocular pressure measuring implant, terminal equipment and an implanting method in human eyeball scleral, aiming at solving the problems that the original method of adopting a deformation sensor to measure corneal deformation (the cornea changes along with the intraocular pressure to a certain degree of shape (curvature)), the mode has the problems that the sensor is not firmly and stably combined with the corneal surface, the deformation transmission is not reliable, and the measuring result is not accurate; can not be worn for a long time, and is easy to generate inflammatory reaction of cornea and conjunctiva.
The invention is realized in this way, a method for implanting an intraocular pressure measurement implant in the sclera of a human eyeball, wherein an interlayer is formed by windowing the sclera of the human eyeball, and the intraocular pressure measurement implant for measuring the radial pressure in the sclera of the eyeball is implanted into the interlayer, and the intraocular pressure measurement implant is converted into the pressure of the inner wall of the sclera of the eyeball (namely intraocular pressure) through mechanical calculation and calibration by external terminal equipment, wherein: the sclera windowing is sutured by adopting a suture mode with tension or adjustable tension.
Further: an implantation method of an intraocular pressure measuring implant in the sclera of a human eyeball comprises the following steps:
firstly, a window with a certain thickness is manufactured on a sclera in a certain form to form an interlayer without penetrating the sclera;
step two, placing the intraocular pressure measuring implant into the interlayer;
thirdly, suturing the sclera windowing, and adjusting the tension of the suture line by using a pull suturing device in the suturing process;
and step four, measuring intraocular pressure in a traditional mode to serve as a calibration reading, adjusting the reading of the intraocular pressure measurement implant by adjusting the tension of the suture, enabling the reading of the intraocular pressure measurement implant to reach a set range, and establishing a set intraocular pressure measurement implant stress.
And fifthly, observing intraocular pressure measurement values after calibration is completed, knotting the suture line after the intraocular pressure measurement values are stabilized, completing the suture, and removing the tension suturing device.
Further: the fenestrated scleral incision is used to retain and reconstruct the stressed structure of the incision, and includes the use of an artificial, foreign or autologous flap of material that is placed directly over the sclera so that the flap forms an interlayer with the sclera, and the retention of a partial incision that is typically used to make an interlayer to cover the tonometric implant.
Further: suture methods with or without tension adjustment are used, which may be "fishbone suture" cemented "sintered suture" or the like, including those using sutures and tension sutures.
Further: tension transmission is established between the scleral flap of the fenestration sandwich and the surrounding scleral tissue through the suture with tension, thereby establishing the force on the tonometric implant.
Further: the use method of the pull stitching instrument comprises the following steps: step S1, the suture needle is passed through the two sides of the incision in the conventional manner, the suture thread is drawn out, the two sides of the suture thread are wound and passed, and the suture knots are narrowed by pulling the suture thread on the two sides after passing, and are slightly tightened until the incision is closed (first knot).
And step S2, opening the left and right clamps of the tension suturing device, respectively fixing the two sides of the suture to the clamps on the left and right sides of the tension suturing device, slightly tensioning the suture to keep the tension state, and closing the clamps on the tension suturing device under the tension state of the suture to enable the clamps to clamp the suture.
Step S3, adjusting the target tension value of the tension stitching instrument, driving the tension stitching instrument to tension the pressure pump to push the swing arm of the clamp holder outwards, and tensioning the suture line to the target tension value;
step S4, knotting the knot of the first suture line (the suture line clamped by the tension suture instrument) by using the second suture line, and locking the knot of the first suture line;
and step S5, the tension pressure pump on the tension suturing device is tensioned to release pressure, the grippers on the two sides are opened, the suture lines are loosened, and at the moment, the tension on the first suture line is maintained as the second suture line is knotted and locked.
And step S6, knotting the first suture line again to form a firm dead knot between the first suture line and the second suture line, and finishing the suture.
The invention is realized in this way, an intraocular pressure measuring implant in the sclera of a human eyeball, which comprises a film-shaped pressure sensor and a chip which is implanted into an interlayer together to complete the functions of complete measurement, data conversion and data communication and is packaged by a biocompatible material, wherein: the pressure sensor measures the pressure (pressure, stress) inside the interlayer, which is perpendicular to the pressure sensor inside the interlayer.
Further: the chip comprises a measuring circuit for converting the electrical characteristics of the sensor into electrical signals, a radio frequency transceiving circuit for wireless communication and an electromagnetic induction coil for radio frequency transceiving, wherein the electromagnetic induction coil can be in a single-turn or multi-turn form and is implanted into the sclera.
The invention is realized in such a way that the terminal equipment matched with the intraocular pressure measuring implant in the human eyeball sclera is connected with the external terminal equipment of the intraocular implant chip in a wireless induction way, the terminal equipment transmits electric energy into the intraocular chip, receives the result sent by the intraocular chip after measurement, and converts the measured original data into the intraocular pressure value to be measured according to a mechanical formula or an empirical formula through a calculation program.
Compared with the prior art, the invention has the beneficial effects that: the invention relates to an implantation method of intraocular pressure measurement implant in human eyeball sclera, which comprises the steps of suturing a sclera flap or a pressure sensor by adopting a suture line with controllable tension to reconstruct the stress and transmitting the stress to the pressure sensor, calibrating the pressure sensor by adjusting the tension on the suture line during operation, thereby establishing the measurement capability which can be obtained immediately, degrading the suture line (if a degradable suture line is used) along with the healing of scleral tissues in the long term after the operation, and transmitting the stress to the pressure sensor by the sclera instead of the suture line, thereby ensuring the long-term usability, having the benefit that the stress can be established in the sclera or on the surface by suturing the sclera or the pressure sensor no matter whether a variant scleral flap is used, reducing the requirement on the implantation position, having the benefit that an interlayer structure is manufactured in the sclera or on the scleral surface and the intraocular pressure measurement implant is implanted, does not penetrate the eyeball or extract the contents of the eyeball, reduces the surgical requirements and risks and has lower risk of inflammatory reactions.
An intraocular pressure measuring implant and a terminal device in human eyeball sclera are used for measuring by adopting different mechanical mechanisms, and based on the requirement of ophthalmology, the intraocular pressure measuring implant and the terminal device are simpler and more convenient for a patient to measure for a long time, and the measuring device can be fixed at a better measuring position for a long time by matching with external terminal equipment placed on the spectacle frame and the eyeshade, and does not need manual cooperation or fixed instrument configuration, etc., and has the advantages of cooperating with automatic program setting, can measure intraocular pressure continuously and frequently for a long time without manual and deliberate operation, can lead patients to live and work normally, leads external terminal equipment to measure automatically for 24 hours, the full-automatic, high-frequency developments intraocular pressure measuring capability, in addition, external terminal equipment only need regularly change measuring equipment battery to upload data or guarantee wireless network connection can.
Drawings
FIG. 1 is a diagram of scleral windowing with unilateral windowing, contralateral bilateral windowing, and trilateral windowing in sequence from left to right in accordance with the present invention;
FIG. 2 is an implant form of the pressure sensor arrangement of the present invention (left) and an implant form of the tension sensor (right);
FIG. 3 is two different coil placement formats of the present invention, a single piece coil placement (left) and a split coil placement (right);
FIG. 4 is a workflow of the implant of the present invention (both digital and analog);
FIG. 5 is a monolithic package (left) and a singulated package (right) of the present invention;
FIG. 6 is a block diagram of an in vitro terminal device of the present invention;
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is described in further detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.
Referring to fig. 1-6, the present invention provides a technical solution: an implantation method of an intraocular pressure measuring implant in the sclera of a human eyeball comprises the following steps:
mechanical description of spherical pressure vessel (eyeball): a spherical thin-walled pressure vessel with its interior pressure equal (contents, liquid or gas) and equal to the pressure on the vessel inner wall (force balance). The pressure outside the vessel is equal to atmospheric pressure. Inside the thin wall, the internal pressure is balanced by the component force of the tension between the layers generated along the spherical radius under the action of the curvature. Therefore, the invention focuses on the theory that a pressure sensor for measuring radial pressure is placed between layers, and the radial pressure is recovered by reconstructing the tension between the layers. Theoretically, the radial pressure decreases in a certain curve from the inner wall to the outer wall, and therefore, the radial pressure and the inner wall pressure are in a certain ratio between layers at a certain depth, whereby the intraocular pressure can be calculated. In actual operation, according to traditional accurate intraocular pressure measurement data and pressure sensor reading, the coefficient can be conveniently reversely deduced, and measurement calibration is completed. During operation, the tension on the suture line and the scleral flap can be adjusted according to actual conditions to change the coefficients of the sensor and the intraocular pressure, so that the operation is convenient.
An implantation surgery step of an intraocular pressure measuring implant in the sclera of a human eyeball:
first, the sclera is fenestrated, and after the conjunctiva is incised, the sclera is fenestrated with a scalpel or a special instrument. As shown in fig. 1, the fenestration may be one-sided, bilateral, or three-sided, and the thickness may be theoretically any thickness, but the fenestration is performed in the middle region of the scleral thickness as much as possible in consideration of safety, handling ease, and the like. Different parts can be implanted in the fenestration according to different designs of the implant, but at least the pressure sensor of the implant is contained, and the rest parts, such as a coil, a measuring circuit and the like, can not be placed in the fenestration area.
And secondly, implanting an intraocular pressure measuring implant in the scleral fenestration. The intraocular pressure measuring implant comprises a pressure sensor of a membrane, a coil and other parts of the implant, such as a measuring circuit, a radio frequency circuit and the like, and is placed in a fenestrated scleral flap, wherein the coil can be implanted in other forms in the scleral, such as after the scleral flap is additionally made; or, a special instrument is used for winding a single-turn or multi-turn coil in the sclera in a circle form on the rear side of the corneoscleral margin and parallel to the corneoscleral margin; in the same way, other parts of the implant can be implanted into the same fenestrated scleral flap as the pressure sensor, and can also be implanted into the scleral flap additionally. Alternatively, the portion may be sutured or otherwise secured directly to the scleral surface and then covered with a flap (artificial material, alloplastic flap, autologous scleral flap, etc.) and sutured afterwards, i.e., as long as the fixation and separation from the conjunctiva is achieved. For a tension sensor: the tension sensor can be directly sutured on the surrounding sclera in a scleral flap windowing mode through tension suturing, or suturing with tension can be directly carried out on the surface of the sclera, and the tension sensor is sutured after being covered with the flap (only plays a role in fixation and does not do tension suturing) for protecting the tension sensor.
Third, stitching with tension, as shown in fig. 2, for a pressure sensor: when one-side, opposite-side, and three-side windowing is adopted, the stress of the sclera at the windowing position can be recovered by adopting a suture technology with tension, so that the pressure sensor can obtain the measurement capability immediately after being implanted. Wherein a three-sided fenestration must require a suture with tension, otherwise the pressure sensor theoretically reads zero. When an artificial, foreign body or autologous valve is adopted, the valve is sutured on the sclera by a suturing technology with tension, and a sandwich structure similar to the sclera windowing and stress characteristics are established, so that the pressure sensor can obtain the measurement capability immediately after being implanted. The pull sutures described above refer to sutures to the scleral flap, not to sutures between the pressure sensor and the sclera. For a tension sensor: the tension sensor must perform a pull suture between the sensor and the surrounding sclera to restore tension and obtain measurements. The pull sutures described above refer to the sutures of the tension sensor to the sclera, not to the sclera. As shown in fig. 3, the coil of the pressure sensor is implanted: when the small coil is adopted, the coil can be directly placed in a scleral flap fenestration or other positions and then sewn and fixed according to the mode of implanting a pressure sensor or a chip; when a large coil is desired, it is necessary to perform the coil implantation and winding steps after passing the catheter in the sclera with a special device during the procedure.
The fourth step, intraocular pressure calibration, is that the pressure measured by the pressure sensor theoretically and the tension measured by the tension sensor are related to the actual intraocular pressure, the suturing force of the scleral flap (or the suturing force between the pressure sensor and the scleral) and the thickness of the scleral flap (i.e. the depth of the pressure sensor in the scleral). In view of the error of scleral flap suturing force and scleral flap thickness, and the change of mechanical environment caused by the healing and reconstruction of scleral tissue and the degradation of the suture after operation, the intraocular pressure is measured by adopting a standard intraocular pressure measuring method and then calibrated by adopting an implant measuring method during and after the operation. In this way, an accurate intraocular pressure measurement can be obtained.
A method for using a tension stitching instrument in the implantation operation step of an intraocular pressure measuring implant in the sclera of a human eyeball comprises the following steps: first, a needle is inserted through the incision and the suture is wound into an O-shape, as is conventional. And secondly, the left side and the right side of the suture line are pulled outwards and placed on a pulley at the top end of a swing arm of the stitching device holder (the suture line is prevented from being damaged during tensioning). And thirdly, the suture is passed through the clamp, and the clamp is closed to clamp the suture. Fourthly, the hydraulic cylinder is operated to push the swing arm of the clamp holder outwards, so that the O-shaped ring of the suture is tensioned, and the tension on the suture can be obtained through the structural size and hydraulic calculation on the hydraulic cylinder, so that the aim of accurately controlling the tension of the suture is fulfilled. And fifthly, the suture line pulling force is provided by the stitching instrument. The knot of the first suture thread is tied (tightened) with a second suture thread. And sixthly, loosening the clamp of the stitching instrument, wherein the first stitching line cannot be loosened because the second stitching line tightens the knot of the first stitching line. And then quickly binding the first suture to the knot of the second suture by means of knotting to complete knotting. At this point, the tension on the suture does not relax.
An tonometric implant within the sclera of a human eyeball:
tonometry implants, i.e. implants on the scleral surface or in the sclera, a device for measuring tonus by wireless means, comprising three major components; respectively a pressure sensor, an electromagnetic induction coil and other partial circuits. The three parts can be designed on a flexible substrate according to the situation, can be matched in pairs and can also be independently placed. The finished product is packaged by adopting a biocompatible flexible material. As shown in figure 4 of the drawings,
wherein the pressure sensor is used for measuring the scleral tissue stress caused by the intraocular pressure on the sclera, and converting the measured value into the intraocular pressure value through calculation and calibration. According to the sphere pressure vessel theory, when intraocular pressure is present in the eyeball, solid stress will be created on the sclera (the pressure vessel shell). In which there is a tensile force (hereinafter referred to as tensile force) in the spherical direction and a compressive force (hereinafter referred to as compressive force) in the eyeball radial direction. For the tension on the sclera, the tension gradually decreases along a quadratic curve from the inner surface to the outer surface, but the change amount of the tension is small because the radius difference between the inner surface and the outer surface is small (the thickness of the sclera is 1-2 mm); for scleral pressure, the decrease from the inner surface to 0 (from intraocular pressure to atmospheric pressure) is along a quadratic curve. According to the mechanics principle, the scleral pressure generated on the sclera by the intraocular pressure can be measured in the sclera (i.e. not on the outer surface of the sclera); scleral tension can be measured anywhere within the sclera, including the inner and outer surfaces. In practice, due to surgical procedures, incision and fenestration of the sclera, including the use of heterologous scleral flaps, etc., can damage the stressed structure of the sclera, resulting in an implanted pressure sensor that may not detect the desired tension or pressure, and requires the maintenance and restoration of mechanical conduction around the pressure sensor by planning the surgical incision or assisting in the use of suture techniques with tension, so that the pressure sensor can measure the tension or tension. In order to facilitate intrascleral implantation and avoid excessive change of the shape of the sclera, a sheet pressure and tension sensor with small thickness is selected. Preferably, a thin film sensor, or a micro pressure, tension sensor fabricated using micro electro mechanical MEMS technology, etc. may be used.
Wherein the measuring circuit is adapted to convert the electrical properties of the pressure sensor into an actual electrical signal. The electrical signal may be an analog signal (i.e., current, voltage, frequency, etc.) or a digital signal (i.e., 01 magnitude). The signal output by the measuring circuit needs to be used, modulated and demodulated by the radio frequency circuit, so that the signal is sent to the extracorporeal terminal equipment through the radio frequency module. In order to simplify the circuit, reduce the implanted volume as much as possible, send the original signal as much as possible, and do not perform excessive processing. And the signal processing and analysis calculation are realized on the in-vitro terminal equipment. The radio frequency circuit is used for receiving and transmitting signals and data. The power supply is used for rectifying and filtering alternating current induced on the electromagnetic induction coil into electrical equipment, and comprises a power supply required by a measuring circuit and a radio frequency circuit. Capacitive energy storage elements may be included to maintain a constant supply of power for a measurement cycle, including the power requirements for data transmission using radio frequency circuitry and electromagnetic coils.
The electromagnetic induction coil is formed by winding a thin insulated wire, and the number of turns and the surrounding shape are determined according to the power utilization condition. According to the electromagnetic induction principle, a primary coil and a secondary coil (the primary coil is defined as a coil on an extracorporeal terminal device, and the secondary coil is defined as a coil on an intraocular pressure measuring implant) are matched, and after alternating current is conducted on the primary coil, alternating electromotive force is induced on the secondary coil. The voltage drives the load circuit, and electric energy can be transmitted to an electric appliance of the intraocular pressure measuring implant in an electromagnetic induction mode. During measurement, a primary coil of the extracorporeal terminal equipment is loaded with a large alternating current to generate a strong enough alternating electromagnetic field, and enough electric energy is transferred to a secondary coil of the intraocular pressure measurement implant. Meanwhile, if some analog or digital signals need to be transmitted, the signals can be superposed on the power pulses in a frequency division mode. And after receiving the signals, the secondary coil extracts the signals of the target frequency band in the form of a filter. The circuit in the tonometric measurement implant is activated by the power supply of the secondary coil, and a measurement is made and conducted to the radio frequency module. The primary coil of the extracorporeal terminal device now becomes the receiving coil, receiving the signal emitted by the secondary coil on the tonometric implant. As described above, a round trip of power-measurement signal transmission is completed, i.e., a tonometry measurement is completed.
Wherein the encapsulation form of the implant is encapsulated by a biocompatible flexible material. As shown in fig. 5, can be divided into 3 major parts, including the coil (antenna), sensor and circuit (chip) parts. These 3 portions may be inherited to a flexible substrate to form a one-piece implant, or may be combined two-by-two or packaged separately.
A matched terminal device of intraocular pressure measuring implant in human eyeball sclera comprises:
the external terminal device refers to a measuring device which is used together with the scleral implant and is handheld, fixed or wearable.
As shown in fig. 6, the in vitro terminal device includes a primary electromagnetic induction coil, a radio frequency module, an embedded platform, and other core components; the system also comprises a screen for man-machine interaction, audio equipment, a key touch screen and the like; the device also comprises a power supply system and a battery; the system also comprises a wireless network module for network communication and the like; wherein the electromagnetic induction coil is used in match with the electromagnetic induction coil in the scleral implant. Wherein, the radio frequency module function includes: providing a high-power alternating electromagnetic field to an electromagnetic induction coil in the scleral implant so as to transmit electric energy required by measurement; secondly, providing signals to an electromagnetic induction coil in the scleral implant; and thirdly, receiving a measurement result signal transmitted by the electromagnetic induction coil in the scleral implant. The embedded platform is a general embedded platform, and executes functions including measurement data resolving, measurement flow control, human-computer interaction, data analysis, storage, uploading and the like. The power supply comprises two parts, one is the power supply of the whole device, and a common rechargeable battery is adopted; one is a high power, high frequency current source (which may also be considered as included in the rf module) that powers the rf module to generate a sufficiently large alternating current on the primary coil to generate a sufficiently strong alternating magnetic field to deliver sufficient electrical energy to the scleral implant.
Regarding the intraocular pressure calculating section of the extracorporeal terminal apparatus: the sclera implant transmits the measured original data back to the external terminal equipment, and the intraocular pressure to be measured is converted by the calculation program on the sclera implant according to a mechanical formula or an empirical formula. When the tissue is implanted, after the tissue is implanted and in the long-term use process, the tissue structure reconstruction phenomenon may exist in scleral tissues and the like, and the mechanical properties are slightly changed. Recalibration may be required to obtain a more accurate calculated value. The traditional accurate tonometer is adopted to measure the intraocular pressure, then the intraocular pressure value is input into measuring equipment, an application interface and the like, and a program can calibrate a calculation formula according to the input reference intraocular pressure value, so that the intraocular pressure obtained by calculation is more accurate. If the signal is a return analog signal, the signal needs to be processed and converted into a digital signal; if the signal is a return digital signal, the signal may need to be verified;
data processing section regarding extracorporeal terminal apparatus: the data processing means that the historical intraocular pressure data and the current intraocular pressure data are stored, judged and analyzed, and statistical values, icons and the like are calculated, so that the intraocular pressure data can be conveniently viewed and analyzed. Including, historical intraocular pressure curves; rate of change of intraocular pressure; intraocular pressure threshold alarm; other related functions.
Regarding the man-machine interaction part of the in vitro terminal device: the human-computer interaction mainly refers to a visual interface and input and output equipment, so that a user can conveniently set, check data, operate and the like.
Internet platform for in vitro terminal devices: each in vitro test device is provided with a wireless or wired network communication module, a server and a software platform are arranged at the rear part, the intraocular pressure of each patient is timely sent to the rear server for unified monitoring and processing, and when a problem occurs, if the intraocular pressure of a certain patient is monitored to be abnormal, an alarm can be directly sent to a doctor (or a guardian) for main treatment. Client software in platform software: in order to facilitate the use of patients and family members, the client of platforms such as intelligent mobile equipment and personal computers are provided together, and the main functions of the client are similar to those of external terminal equipment. A back-end service platform in the platform software: and a regional back-end service platform is established, and the main function of the regional back-end service platform is to monitor intraocular pressure real-time data of each returned patient in real time. The data are monitored, analyzed and recorded, and when problems occur, alarms are provided for butted medical care or guardians and institutions in time. Big data platform in platform software: on the basis of a large amount of long-term intraocular pressure data of patients, the intraocular pressure data is learned and analyzed by combining with diagnosis and treatment records of ophthalmology and adopting modes of deep learning, pattern recognition and the like so as to mine the diagnosis and early warning significance of intraocular pressure information on ophthalmic diseases.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents and improvements made within the spirit and principle of the present invention are intended to be included within the scope of the present invention.
Claims (9)
1. A method of implanting an tonometric implant within the sclera of a human eyeball, comprising: windowing on the sclera of human eyeball and making the intermediate layer to implant the intraocular pressure measurement implant that is used for measuring the radial pressure in the eyeball sclera to this intermediate layer, the intraocular pressure measurement implant passes through external terminal equipment and through mechanics calculation and demarcation, converts eyeball sclera inner wall pressure intensity into, intraocular pressure, wherein: the sclera windowing is sutured by adopting a suture mode with tension or adjustable tension.
2. A method of implanting an tonometric implant according to claim 1, comprising the steps of:
firstly, a window with a certain thickness is manufactured on a sclera in a certain form to form an interlayer without penetrating the sclera;
step two, placing the intraocular pressure measuring implant into the interlayer;
thirdly, suturing the sclera windowing, and adjusting the tension of the suture line by using a pull suturing device in the suturing process;
and step four, measuring the intraocular pressure in a traditional mode to serve as a calibration reading, and adjusting the tension of the suture to adjust the reading of the intraocular pressure measurement implant so that the reading of the intraocular pressure measurement implant reaches a set range.
And fifthly, observing intraocular pressure measurement values after calibration is completed, knotting the suture line after the intraocular pressure measurement values are stabilized, completing the suture, and removing the tension suturing device.
3. A method of implanting an tonometric implant within the sclera of a human eye as defined in claim 2, wherein: the fenestrated scleral incision is used to retain and reconstruct the stressed structure thereof and includes the use of an artificial or foreign body flap material directly overlying the sclera, such that the flap forms an interlayer with the sclera, and the retention of a partial incision, the interlayer being fabricated to cover the tonometric measurement implant.
4. A method of implanting an tonometric implant within the sclera of a human eye as defined in claim 1, wherein: the suture mode is a suture mode with tension or adjustable tension, and the suture mode is a fishbone suture line ' bonding ' sintered suture line ', wherein the suture mode and the tension suture device are used.
5. A method of implanting an tonometric implant within the sclera of a human eye as defined in claim 2, wherein: tension transmission is established between the scleral flap of the fenestration sandwich and the surrounding scleral tissue through the suture with tension, thereby establishing the force on the tonometric implant.
6. A method of implanting an tonometric implant according to claim 4, wherein: the use method of the pull stitching instrument comprises the following steps: and step S1, the suture needle is passed through two sides of the incision according to the traditional mode, the suture line is led out, two sides of the suture line are wound and passed through, the suture line at two sides is pulled to shrink the suture knot after being passed through, and the suture knot is slightly tensioned until the incision is closed, namely the first suture knot.
And step S2, opening the left and right clamps of the tension suturing device, respectively fixing the two sides of the suture to the clamps on the left and right sides of the tension suturing device, slightly tensioning the suture to keep the tension state, and closing the clamps on the tension suturing device under the tension state of the suture to enable the clamps to clamp the suture.
Step S3, adjusting the target tension value of the tension stitching instrument, driving the tension stitching instrument to tension the pressure pump to push the swing arm of the clamp holder outwards, and tensioning the suture line to the target tension value;
step S4, knotting the knot on the suture line clamped by the first suture line, namely the tension suture device, by using the second suture line, and locking the knot of the first suture line;
and step S5, the tension pressure pump on the tension suturing device is tensioned to release pressure, the grippers on the two sides are opened, the suture lines are loosened, and at the moment, the tension on the first suture line is maintained as the second suture line is knotted and locked.
And step S6, knotting the first suture line again to form a firm dead knot between the first suture line and the second suture line, and finishing the suture.
7. Use of an intraocular pressure measuring implant according to any one of claims 1 to 6, wherein: the intraocular pressure measuring implant comprises a film-shaped pressure sensor and a chip which is implanted into an interlayer together and is packaged by a biocompatible material to complete the functions of measurement, data conversion and data communication, wherein: the pressure sensor measures the pressure, i.e. the pressure intensity, inside the interlayer, which is measured by the pressure sensor in the interlayer perpendicular to the pressure sensor.
8. An intraocular pressure measuring implant according to claim 7 wherein: the chip comprises a measuring circuit for converting the electrical characteristics of the sensor into electrical signals, a radio frequency transceiving circuit for wireless communication and an electromagnetic induction coil for radio frequency transceiving, wherein the electromagnetic induction coil can be in a single-turn or multi-turn form and is implanted into the sclera.
9. A terminal device for use with an intraocular pressure measuring implant according to any one of claims 1 to 8, wherein: and the terminal equipment transmits electric energy into the intraocular chip, receives a result sent by the intraocular chip after measurement, and converts the measured original data into an intraocular pressure value to be measured through a calculation program according to a mechanical formula or an empirical formula.
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