A non-invasive intraocular pressure absolute value measuring system and method thereof

Abstract

The application relates to a non-invasive intraorbital pressure absolute value measuring system and method thereof, which comprises a retinal vascular blood pressure meter, an ophthalmoscope, an ultrasonic diagnostic instrument and a processor, and the method comprises the following steps: applying pressure to an eyeball by using the retinal vascular blood pressure meter and measuring intraocular pressure change data; simultaneously observing the change state of a retinal central vein during the pressure application process by using the ophthalmoscope; when the retinal central vein is observed to be sunken by using the ophthalmoscope, recording the intraocular pressure data measured by the retinal vascular blood pressure meter at this time, which is retinal vein pressure data; respectively measuring the optic nerve sheath diameter data at the positions of 0 mm and 3 mm behind the eyeball wall by using the ultrasonic diagnostic instrument; and calculating the intraorbital pressure data by the processor according to the measured retinal vein pressure data, the optic nerve sheath diameter data at the positions of 0 mm and 3 mm behind the eyeball wall. Compared with the prior art, the application can non-invasively and accurately measure the intraorbital pressure data.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a non-invasive system and method for measuring the absolute value of intraorbital pressure. Background Technology

[0002] Intraorbital pressure refers to the pressure within the orbit surrounding the eyeball, also known as orbital pressure. The orbit is the space enclosed by the orbital fossa or orbital bone, containing structures such as the eyeball, extraocular muscles, and orbital fat. Measuring intraorbital pressure helps doctors assess and monitor the severity and progression of orbital diseases in patients.

[0003] Currently, the detection of intraorbital pressure is mainly divided into two methods: direct and indirect. The direct method involves placing a pressure sensor or catheter inside the orbit to directly measure the intraorbital pressure. This device can accurately measure the pressure, but this method may cause discomfort and infection risks for patients, especially those with other diseases or poor health. The indirect method involves imaging the orbit or using specific detection methods to indirectly infer changes in intraorbital pressure. This method does not require surgery or invasive procedures and is a non-invasive measurement method. However, this method is actually only a rough qualitative estimate and cannot provide a precise measurement value. Its accuracy is affected by various factors, such as the precision of the imaging technology and the anatomical structure of the eyeball and orbital tissues.

[0004] Therefore, how to measure intraocular pressure non-invasively and accurately is a technical problem that urgently needs to be solved. Summary of the Invention

[0005] The purpose of this invention is to overcome the shortcomings of the prior art by providing a non-invasive system and method for measuring the absolute value of intraorbital pressure, which can detect intraorbital pressure non-invasively and accurately.

[0006] The objective of this invention can be achieved through the following technical solution: a non-invasive system for measuring the absolute value of intraocular pressure, comprising a retinal vascular sphygmomanometer, an ophthalmoscope, an ultrasound diagnostic instrument, and a processor, wherein the retinal vascular sphygmomanometer is used to apply pressure to the eyeball and measure intraocular pressure changes.

[0007] The ophthalmoscope is used to observe the changes in the central retinal vein during the application of pressure to the eyeball.

[0008] The ultrasound diagnostic instrument is used to measure the diameter of the optic nerve sheath at a distance of 3 mm behind the optic nerve wall and the diameter of the optic nerve sheath directly behind the optic nerve wall.

[0009] The processor calculates the intraocular pressure data based on the intraocular pressure data measured by the retinal vascular sphygmomanometer and the diameter data of the optic nerve sheath behind the spherical wall obtained by the ultrasound diagnostic instrument.

[0010] Furthermore, the retinal vascular blood pressure monitor is equipped with a negative pressure suction cup for applying pressure from the side of the eyeball.

[0011] Furthermore, the retinal vascular blood pressure monitor is specifically a spring-loaded retinal vascular blood pressure monitor.

[0012] Furthermore, the probe of the ultrasound diagnostic instrument is a 7.5MHz high-frequency probe.

[0013] A non-invasive method for measuring the absolute value of intraorbital pressure, comprising the following steps:

[0014] S1. Apply pressure to the eyeball using a retinal vascular sphygmomanometer and measure changes in intraocular pressure.

[0015] Simultaneously, ophthalmoscopy was used to observe the changes in the central retinal vein during the application of pressure to the eyeball;

[0016] S2. When the central retinal vein is observed to be indented using an ophthalmoscope, record the intraocular pressure data measured by the retinal vascular sphygmomanometer at this time, which is the retinal vein pressure data.

[0017] S3. Using an ultrasound diagnostic instrument, the diameter of the optic nerve sheath at 0 mm and 3 mm behind the optic nerve wall was measured respectively.

[0018] S4. Based on the data obtained in steps S2 and S3, the processor calculates the intraorbital pressure data.

[0019] Further, the specific process of step S1 is as follows: the head of the retinal vascular sphygmomanometer is disinfected with 75% ethanol, and then the retinal vascular sphygmomanometer is placed vertically on the sclera at the insertion of the lateral rectus muscle, and pressure is gradually applied.

[0020] Further, the specific process of step S3 is as follows: In order to prevent pressure on the eyeball, cross-sectional scanning and sagittal scanning are used to obtain images that can display the boundary of the optic nerve sheath under the acoustic transmission of the vitreous body. Then, the equipment parameters of the ultrasound diagnostic instrument are adjusted to measure the corresponding optic nerve sheath diameter data at 0mm and 3mm behind the eyeball wall, respectively.

[0021] Furthermore, adjusting the equipment parameters of the ultrasound diagnostic instrument in step S3 specifically refers to adjusting the output intensity and ultrasound gain.

[0022] Furthermore, step S3 specifically involves taking two measurements at 0mm and 3mm behind the optic nerve wall and averaging them to obtain the corresponding optic nerve sheath diameter data.

[0023] Furthermore, the formula for calculating the intraorbital pressure data in step S4 is as follows:

[0024] Intraorbital pressure = retinal venous pressure / 2 - (diameter of optic nerve sheath 3 mm posterior to the retinal wall - diameter of optic nerve sheath 0 mm posterior to the retinal wall) / 0.05.

[0025] Compared with the prior art, the present invention has the following advantages:

[0026] I. This invention utilizes a retinal vascular sphygmomanometer, ophthalmoscope, ultrasound diagnostic instrument, and processor. The retinal vascular sphygmomanometer applies pressure to the eyeball and measures intraocular pressure changes. The ophthalmoscope observes the changes in the central retinal vein during the application of pressure. The ultrasound diagnostic instrument measures the diameter of the optic nerve sheath 3 mm posterior to the eyeball wall and the diameter of the optic nerve sheath directly posterior to the eyeball wall. The processor calculates the intraocular pressure based on the intraocular pressure data measured by the retinal vascular sphygmomanometer and the optic nerve sheath diameter data measured by the ultrasound diagnostic instrument. This provides a non-invasive measurement method that accurately measures intraocular pressure without surgery or other invasive procedures.

[0027] II. This invention considers the correlation between retinal venous pressure and downstream pressure changes, thus deriving retinal venous pressure = intracranial pressure + intraorbital pressure. Intracranial pressure can be indirectly reflected by the diameter of the optic nerve sheath. Therefore, an ultrasound method is designed to measure the diameter of the optic nerve sheath posterior to the eyeball. Furthermore, considering that the optic nerve sheath diameter connected to the sclera is limited by the sclera, the diameter fluctuation in this part is minimal, while the optic nerve sheath 3 mm posterior to the sclera has the greatest mobility. Therefore, the following formula is determined: Intracranial pressure = Intraorbital pressure + (Diameter of the optic nerve sheath 3 mm posterior to the sclera - Diameter of the optic nerve sheath directly posterior to the sclera) / 0.025. Finally, the formula for calculating intraorbital pressure is: Intraorbital pressure = Retinal venous pressure / 2 - (Diameter of the optic nerve sheath 3 mm posterior to the sclera - Diameter of the optic nerve sheath directly posterior to the sclera) / 0.05. This invention can quickly and accurately obtain intraorbital pressure data by measuring retinal venous pressure, the diameter of the optic nerve sheath 3 mm posterior to the sclera, and the diameter of the optic nerve sheath directly posterior to the sclera.

[0028] Third, in measuring retinal venous pressure, this invention uses a retinal vascular sphygmomanometer to apply pressure to the eyeball and measure the changes in intraocular pressure. At the same time, an ophthalmoscope is used to observe the changes in the central retinal vein during the process of applying pressure to the eyeball. When the ophthalmoscope observes that the central retinal vein is indented, the intraocular pressure data measured by the retinal vascular sphygmomanometer at this time is recorded, which is the retinal venous pressure data. This can fully ensure the reliability of retinal venous pressure measurement.

[0029] IV. This invention uses an ultrasound diagnostic instrument. To prevent pressure on the eyeball, transverse and sagittal scans are employed. Under the acoustic transmission of the vitreous body, clear images can be obtained, showing the course of the optic disc and optic nerve, and clearly displaying the hyperechoic area around the optic nerve. Then, the ultrasound beam is focused on the retrobulbar region, and the output intensity and ultrasound gain are adjusted to clearly display the boundary of the optic nerve sheath. Measurements are taken at 0mm and 3mm behind the eyeball wall, and each section is measured twice and the average value is taken. This can minimize inter-observer variability and further ensure the accuracy of the measurement data. Attached Figure Description

[0030] Figure 1 This is a schematic diagram of the method flow of the present invention;

[0031] Figure 2 This diagram illustrates the relationship between retinal venous pressure and intracranial and intraorbital pressure. Detailed Implementation

[0032] The present invention will now be described in detail with reference to the accompanying drawings and specific embodiments.

[0033] Example

[0034] A non-invasive system for measuring the absolute value of intraocular pressure includes a retinal vascular sphygmomanometer, an ophthalmoscope, an ultrasound diagnostic instrument, and a processor. The retinal vascular sphygmomanometer is used to apply pressure to the eyeball and measure changes in intraocular pressure. The retinal vascular sphygmomanometer is equipped with a negative pressure suction cup for applying pressure from the side of the eyeball. In this embodiment, a spring-type retinal vascular sphygmomanometer is selected.

[0035] An ophthalmoscope is used to observe changes in the central retinal vein when pressure is applied to the eyeball.

[0036] The ultrasound diagnostic instrument is used to measure the diameter of the optic nerve sheath 3 mm behind the optic nerve wall and the diameter of the optic nerve sheath directly behind the optic nerve wall. In this embodiment, the probe of the ultrasound diagnostic instrument is a 7.5 MHz high-frequency probe.

[0037] The processor calculates the intraocular pressure data based on the intraocular pressure data measured by the retinal vascular sphygmomanometer and the diameter data of the optic nerve sheath behind the spherical wall obtained by the ultrasound diagnostic instrument.

[0038] Based on the above measurement system, a non-invasive method for measuring the absolute value of intraorbital pressure is implemented, such as... Figure 1 As shown, it includes the following steps:

[0039] S1. Apply pressure to the eyeball using a retinal vascular sphygmomanometer and measure changes in intraocular pressure.

[0040] Simultaneously, ophthalmoscopy was used to observe the changes in the central retinal vein during the application of pressure to the eyeball;

[0041] S2. When the central retinal vein is observed to be indented using an ophthalmoscope, record the intraocular pressure data measured by the retinal vascular sphygmomanometer at this time, which is the retinal vein pressure data.

[0042] S3. Using an ultrasound diagnostic instrument, the diameter of the optic nerve sheath at 0 mm and 3 mm behind the optic nerve wall was measured respectively.

[0043] S4. Based on the data obtained in steps S2 and S3, the processor calculates the intraorbital pressure data.

[0044] This scheme takes into account the correlation between retinal venous pressure and downstream pressure changes. The optic nerve sheath (ONS) is a continuation of the dura mater, and the cerebrospinal fluid within it is freely connected to the intracranial cerebrospinal fluid. Pressure can be transmitted to the ONS via the cerebrospinal fluid. The ONS is located within the orbit, and intracranial pressure and intraorbital pressure can be considered as the two main pressures downstream of retinal venous pressure. Therefore, it can be concluded that retinal venous pressure = intracranial pressure + intraorbital pressure (e.g., ...). Figure 2 (As shown).

[0045] After intracranial pressure increases, the cerebrospinal fluid that fills the intracranial cavity gradually enters the subarachnoid space of the optic nerve through the optic canal, causing a certain degree of expansion of the space within the optic nerve sheath. At this time, the expansion of the space within the optic nerve sheath has a corresponding temporal consistency with the increase in intracranial pressure. Therefore, the diameter of the optic nerve sheath can indirectly reflect the level of intracranial pressure.

[0046] Ultrasound measurement of the diameter of the optic nerve sheath posterior to the eyeball is a very effective, non-invasive, and simple examination method. Because the optic nerve sheath, connected to the optic nerve wall, is restricted by the sclera, the diameter of this portion fluctuates the least, while the optic nerve sheath posterior to the optic nerve wall exhibits the greatest mobility in the 3mm posterior portion. When the intracranial pressure (ICP) equals the intraorbital pressure, it can be inferred that the diameter of the optic nerve sheath 3mm posterior to the optic nerve wall equals the diameter of the optic nerve sheath directly posterior to the optic nerve wall. When the ICP is higher (or lower) than the intraorbital pressure, the optic nerve sheath posterior to the optic nerve wall expands (or contracts), while the diameter of the optic nerve sheath directly posterior to the optic nerve wall does not expand (or contract) due to the restriction of the scleral wall, thus causing the diameter of the optic nerve sheath posterior to the optic nerve wall to differ from the diameter of the optic nerve sheath directly posterior to the optic nerve wall. Previous studies have shown that for every 1mmHg increase in ICP, the diameter of the optic nerve sheath 3mm posterior to the optic nerve wall expands by 0.025mm (HANSEN HG). W, KRUEGER O, et al. Dependence of the optic nerve sheath diameter on acutely applied subarachnoidal pressure-an experimental ultrasound study[J]. Acta Ophthalmol, 2011, 89(6):528-e532). Therefore, it can be concluded that intracranial pressure = intraorbital pressure + (diameter of the optic nerve sheath 3 mm posterior to the optic wall - diameter of the optic nerve sheath directly posterior to the optic wall) / 0.025.

[0047] This leads to two formulas:

[0048] 1. Retinal venous pressure = Intraorbital pressure + Intracranial pressure

[0049] 2. Intracranial pressure = Intraorbital pressure + (Diameter of the optic nerve sheath 3mm posterior to the optic nerve wall - Diameter of the optic nerve sheath directly posterior to the optic nerve wall) / 0.025.

[0050] Combining the two formulas above, we get:

[0051] Retinal venous pressure = Intraorbital pressure + Intraorbital pressure + (Diameter of optic nerve sheath 3mm posterior to retinal wall - Diameter of optic nerve sheath directly posterior to retinal wall) / 0.025.

[0052] That is, we get:

[0053] Intraorbital pressure = retinal venous pressure / 2 - (diameter of optic nerve sheath 3 mm posterior to the retinal wall - diameter of optic nerve sheath directly posterior to the retinal wall) / 0.05.

[0054] Therefore, the intraorbital pressure can be obtained by measuring the retinal venous pressure, the diameter of the optic nerve sheath 3 mm behind the retinal wall, and the diameter of the optic nerve sheath directly behind the retinal wall.

[0055] When applying this solution in practice, the main measurement steps include:

[0056] 1. After unilateral eye paralysis and mydriasis, a negative pressure suction cup is placed on the side of the eyeball, and pressure is gradually increased until the central retinal vein is seen to be indented under ophthalmoscopy. During the pressure increase, the intraocular pressure gradually increases and its value is recorded. The intraocular pressure measured when the retinal vein is indented is the retinal venous pressure.

[0057] The following formula is obtained:

[0058] Retinal venous pressure = Intraorbital pressure + Intracranial pressure

[0059] 2. Using an ultrasound diagnostic instrument with a 7.5MHz high-frequency probe and a mechanical index below 0.2, the patient is placed in a supine position with eyelids closed and eyeballs fixed. A thicker coupling gel is gently applied to the temporal region of the closed upper eyelid to prevent pressure on the eyeball. Transverse and sagittal scans are performed. Clear images can be obtained under the acoustic transmission of the vitreous body. The images should show the course of the optic disc and optic nerve, and clearly show the hyperechoic area around the optic nerve. After obtaining appropriate images, the ultrasound beam is focused on the retrobulbar region. The output intensity and ultrasound gain are adjusted to clearly show the boundary of the optic nerve sheath. Measurements are taken at 0mm and 3mm behind the optic wall. To minimize inter-observer variability, each section is measured twice, and the average value is taken.

[0060] The following formula is obtained:

[0061] Intracranial pressure = Intraorbital pressure + (Diameter of the optic nerve sheath 3 mm posterior to the optic nerve wall - Diameter of the optic nerve sheath directly posterior to the optic nerve wall) / 0.025.

[0062] 3. From the above two formulas, we obtain the following formula:

[0063] Retinal venous pressure = Intraorbital pressure + Intraorbital pressure + (Diameter of optic nerve sheath 3mm posterior to retinal wall - Diameter of optic nerve sheath directly posterior to retinal wall) / 0.025;

[0064] Right now:

[0065] Intraorbital pressure = retinal venous pressure / 2 - (diameter of optic nerve sheath 3 mm posterior to the retinal wall - diameter of optic nerve sheath directly posterior to the retinal wall) / 0.05.

[0066] Since the retinal venous pressure, the diameter of the optic nerve sheath 3 mm posterior to the retinal wall, and the diameter of the optic nerve sheath directly posterior to the retinal wall have all been measured, the specific value of the intraorbital pressure can be calculated.

[0067] In this embodiment, the ocular surface to be tested is first anesthetized 2 to 3 times with 0.5% tetracaine or lidocaine eye drops;

[0068] The patient was then instructed to lie supine, and intraocular pressure was measured, along with brachial artery systolic and diastolic pressure.

[0069] For the head of the spring-loaded retinal vascular blood pressure monitor, after disinfecting with a cotton ball soaked in 75% ethanol, place it vertically on the sclera at the insertion of the lateral rectus muscle.

[0070] Then gradually apply pressure, and at the same time observe and measure the collapse of the retinal vein on the optic disc with an ophthalmoscope, record the pressure value as 20 mmHg;

[0071] Then, using an ultrasound diagnostic instrument with a 7.5MHz high-frequency probe and a mechanical index below 0.2, the patient remained supine with eyelids closed. A thicker coupling gel was gently applied to the temporal region of the closed upper eyelid. To prevent pressure on the eyeball, transverse and sagittal scans were performed. Clear images were obtained under the acoustic transmission of the vitreous body. The images were required to show the course of the optic disc and optic nerve, and clearly show the hyperechoic area around the optic nerve. After obtaining appropriate images, the ultrasound beam was focused on the retrobulbar region, and the output intensity and ultrasound gain were adjusted to clearly show the boundary of the optic nerve sheath. Measurements were taken at 0mm and 3mm behind the optic wall. To minimize inter-observer variability, each section was measured twice, and the average value was taken. The average diameter of the optic nerve sheath at 0mm behind the optic wall was 3.75mm, and the average diameter at 3mm behind the optic wall was 4.0mm.

[0072] Finally, according to the formula:

[0073] Intraorbital pressure = retinal venous pressure / 2 - (diameter of optic nerve sheath 3 mm posterior to the retinal wall - diameter of optic nerve sheath directly posterior to the retinal wall) / 0.05.

[0074] The calculation shows that:

[0075] Intraorbital pressure = 20 mmHg / 2 - (4 - 3.75) / 0.05 mmHg

[0076] =10 mmHg - 0.25 / 0.05 mmHg

[0077] =10mmHg - 5mmHg

[0078] =5 mmHg.

[0079] Therefore, the final measured intraorbital pressure was 5 mmHg.

[0080] In summary, this method can obtain intraorbital pressure data in a non-invasive and accurate manner, with no operational risks, and the measurement operation can be repeated.

Claims

1. A non-invasive system for measuring the absolute value of intraorbital pressure, characterized in that, The device includes a retinal vascular sphygmomanometer, an ophthalmoscope, an ultrasound diagnostic instrument, and a processor. The retinal vascular sphygmomanometer is used to apply pressure to the eyeball and measure changes in intraocular pressure. The ophthalmoscope is used to observe the changes in the central retinal vein during the application of pressure to the eyeball. The ultrasound diagnostic instrument is used to measure the diameter of the optic nerve sheath at a distance of 3 mm behind the optic nerve wall and the diameter of the optic nerve sheath directly behind the optic nerve wall. The processor calculates the intraocular pressure data based on the intraocular pressure data measured by the retinal vascular sphygmomanometer and the diameter data of the optic nerve sheath behind the spherical wall obtained by the ultrasound diagnostic instrument.

2. The non-invasive system for measuring the absolute value of intraorbital pressure according to claim 1, characterized in that, The retinal vascular blood pressure monitor is equipped with a negative pressure suction cup for applying pressure from the side of the eyeball.

3. The non-invasive system for measuring the absolute value of intraorbital pressure according to claim 1, characterized in that, The retinal vascular blood pressure monitor is specifically a spring-type retinal vascular blood pressure monitor.

4. The non-invasive system for measuring the absolute value of intraorbital pressure according to claim 1, characterized in that, The probe of the ultrasound diagnostic instrument is a 7.5MHz high-frequency probe.

5. A non-invasive method for measuring the absolute value of intraorbital pressure using the non-invasive intraorbital pressure measurement system as described in claim 1, characterized in that, Includes the following steps: S1. Apply pressure to the eyeball using a retinal vascular sphygmomanometer and measure changes in intraocular pressure. Simultaneously, ophthalmoscopy was used to observe the changes in the central retinal vein during the application of pressure to the eyeball; S2. When the central retinal vein is observed to be indented using an ophthalmoscope, record the intraocular pressure data measured by the retinal vascular sphygmomanometer at this time, which is the retinal vein pressure data. S3. Using an ultrasound diagnostic instrument, the diameter of the optic nerve sheath at 0 mm and 3 mm behind the optic nerve wall was measured respectively. S4. Based on the data obtained in steps S2 and S3, the processor calculates the intraorbital pressure data.

6. The method for measuring the absolute value of intraorbital pressure without invasiveness according to claim 5, characterized in that, The specific process of step S1 is as follows: the head of the retinal vascular sphygmomanometer is disinfected with 75% ethanol, and then the retinal vascular sphygmomanometer is placed vertically on the sclera at the insertion of the lateral rectus muscle, and pressure is gradually applied.

7. The method for measuring the absolute value of intraorbital pressure without invasiveness according to claim 5, characterized in that, The specific process of step S3 is as follows: In order to prevent pressure on the eyeball, cross-sectional scanning and sagittal scanning are used to obtain images that can display the boundary of the optic nerve sheath under the acoustic transmission of the vitreous body. Then, the equipment parameters of the ultrasound diagnostic instrument are adjusted to measure the corresponding optic nerve sheath diameter data at 0mm and 3mm behind the eyeball wall, respectively.

8. A non-invasive method for measuring the absolute value of intraorbital pressure according to claim 7, characterized in that, In step S3, adjusting the equipment parameters of the ultrasound diagnostic instrument specifically refers to adjusting the output intensity and ultrasound gain.

9. A non-invasive method for measuring the absolute value of intraorbital pressure according to claim 7, characterized in that, Specifically, step S3 involves taking two measurements at 0mm and 3mm behind the optic nerve wall and averaging them to obtain the corresponding optic nerve sheath diameter data.

10. A non-invasive method for measuring the absolute value of intraorbital pressure according to any one of claims 5 to 9, characterized in that, The formula for calculating the intraocular pressure data in step S4 is: Intraorbital pressure = retinal venous pressure / 2 - (diameter of optic nerve sheath 3 mm posterior to the retinal wall - diameter of optic nerve sheath 0 mm posterior to the retinal wall) / 0.05.

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