Perioperative pain monitoring device based on ultrasonic technology and monitoring method thereof

CN122874040APending Publication Date: 2026-10-09WEINAN CENT HOSPITAL
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Patent Information

Application Number
CN202410560031.6
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-05-08
Publication Date
2026-10-09

AI Technical Summary

Technical Problem

[0003]现有研究表明瞳孔直径和患者围术期疼痛程度有很强的相关性,但是现有的瞳孔直径检测设备以光学检测为主,一方面患者在全身麻醉手术期间必须保持睁眼状态才能检测,与人体正常闭眼睡眠状态相悖,易引发角膜炎等并发症;一方面睁眼的检测容易受到手术室内光线强弱变化对瞳孔直径的影响而出现误差,不便使用

Benefits of technology

[0031]1、本发明中的疼痛监测设备与传统的光学检测设备相比,采用非侵入性超声波监测技术,无需患者睁眼,从而显著降低了眼部并发症的风险,并减少了因长时间强迫睁眼引发的角膜损伤和感染的可能性,增加了手术过程中患者的安全性。

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Abstract

The application discloses a perioperative pain monitoring device based on ultrasonic technology and a monitoring method thereof, and belongs to the technical field of pain monitoring. The monitoring device comprises an eye cover, two through holes are formed in positions corresponding to eyes on the eye cover, and an ultrasonic probe assembly for collecting pupil ultrasonic data is arranged at each through hole. The ultrasonic probe assembly comprises an ultrasonic probe body and a probe accessory outside the ultrasonic probe body, and a coupling agent injection hole is formed in the probe accessory. In the application, the eyes of a patient are scanned by using an ultrasonic probe, ultrasonic emission signals are acquired, and then the pupil diameter is determined through ultrasonic reflection signals, so that continuous and real-time monitoring of the pain degree of the patient is realized. The non-invasive monitoring method improves the safety of patient pain monitoring, is not disturbed by other external influencing factors, and guarantees the accuracy of measurement.
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Description

Technical Field

[0001] This invention relates to the field of pain monitoring technology, and in particular to perioperative pain monitoring equipment and methods based on ultrasound technology. Background Technology

[0002] The perception of pain is highly dependent on individual subjective experience. However, under general anesthesia, patients lose consciousness and are unable to express pain, making it difficult to directly assess the degree of pain in patients under general anesthesia. Nevertheless, noxious stimuli caused by surgical trauma can induce systemic stress responses, hemodynamic responses, and immunosuppression, making objective monitoring of noxious stimuli perceived by patients during surgery particularly important.

[0003] Existing research indicates a strong correlation between pupil diameter and the degree of perioperative pain in patients. However, current pupil diameter detection equipment is mainly optical. On the one hand, patients must keep their eyes open during general anesthesia to be detected, which contradicts the normal sleep state with eyes closed and can easily lead to complications such as keratitis. On the other hand, detection with eyes open is easily affected by changes in the intensity of light in the operating room, which can cause errors and makes the equipment inconvenient to use. Summary of the Invention

[0004] To address the aforementioned problems, this invention aims to provide a perioperative pain monitoring device and method based on ultrasound technology. The device uses an ultrasound probe to scan the patient's eyes, acquires ultrasound emission signals, and then determines the pupil diameter through ultrasound reflection signals, thereby enabling the monitoring of the patient's pain level.

[0005] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0006] The perioperative pain monitoring device based on ultrasound technology includes an eye mask with two through holes at positions corresponding to the eyes. Each through hole is equipped with an ultrasound probe assembly for collecting ultrasound data from the pupil.

[0007] Furthermore, the ultrasonic probe assembly includes an ultrasonic probe body and a probe accessory located outside the ultrasonic probe body, the probe accessory having a coupling agent injection hole.

[0008] Furthermore, the monitoring device also includes a data processor for processing ultrasound data and analyzing and assessing the degree of pain, the data processor being connected to the ultrasound probe body via a data transmission line.

[0009] Furthermore, the monitoring device also includes a display, which is connected to the data processor.

[0010] Furthermore, the goggles are also equipped with elastic straps.

[0011] Furthermore, the present invention also includes a monitoring method for the pain monitoring device as described above, specifically comprising the following steps:

[0012] S1: Preparation for ultrasound scan;

[0013] S2: Positioning and fixing of the ultrasonic probe assembly;

[0014] S3: Pupil ultrasound scan and data collection;

[0015] S4: Process and analyze the collected ultrasound data, converting it into pain level data;

[0016] S5: Display and monitor the pain level data obtained in step S4 in real time.

[0017] Furthermore, the specific operation of step S2 includes the following steps:

[0018] S201: Attach the probe accessory with the ultrasound probe body to the patient's eyelid, ensuring that the ultrasound probe body is directly above the pupil;

[0019] S202: Inject couplant into the probe fitting through the couplant injection hole;

[0020] S203: Cover the top of the probe accessory with the goggles, ensuring the through-holes in the goggles correspond to the probe accessory, and secure the goggles to the patient's head.

[0021] Furthermore, the specific operation of step S4 includes the following steps:

[0022] S401: After receiving the ultrasonic wave reflection signal, the data processor analyzes the signal characteristics through signal processing algorithms and calculates the pupil diameter.

[0023] S402: Utilize the correlation between pupil diameter and pain intensity to convert pupil diameter data into an assessment value for pain intensity.

[0024] Furthermore, the specific operation of step S401 includes the following steps:

[0025] S4011: The data processor performs signal processing and filtering on the received ultrasonic reflected signal;

[0026] S4012: Analyze the characteristics of the processed signal, including signal strength and time delay;

[0027] S4013: Based on the signal characteristics, the data processor identifies features in the reflected signal that are related to the pupil edge and determines the position of the pupil edge;

[0028] S4014: Calculate the pupil diameter based on the position of the pupil edge.

[0029] Furthermore, in step S402, the pupil diameter is positively correlated with the degree of pain; the greater the rate of change in pupil diameter, the higher the degree of pain, and the greater the rate of change in pupil diameter Δ=│(T n -T0) / T0×100%│, where T0 is the pupil diameter when the patient is not experiencing pain; T n The pupil diameter is measured at any point during the monitoring process.

[0030] The beneficial effects of this invention are:

[0031] 1. Compared with traditional optical detection devices, the pain monitoring device of this invention uses non-invasive ultrasound monitoring technology, which does not require the patient to open their eyes, thereby significantly reducing the risk of ocular complications and the possibility of corneal damage and infection caused by prolonged forced eye opening, and increasing the safety of patients during the operation.

[0032] 2. Compared with traditional optical detection equipment, the pain monitoring device in this invention uses an ultrasonic probe to continuously monitor pupillary response without interfering with the patient's normal eye-closed state. This provides real-time and continuous pain assessment data for perioperative management, ensuring real-time adjustment of anesthesia depth and pain control, and improving monitoring quality.

[0033] 3. Compared with other existing pain monitoring technologies, the pain monitoring method in this invention is unaffected by factors such as arrhythmia, hemodynamic fluctuations, and changes in operating room lighting intensity, ensuring measurement accuracy. Existing monitoring technologies based on heart rate variability are affected by arrhythmia and hemodynamic fluctuations, while technologies based on optical monitoring of pupil diameter are affected by changes in operating room lighting intensity. The ultrasound probe is independent of these variables, making pain monitoring data more stable and reliable, providing strong support for individualized patient treatment. Attached Figure Description

[0034] Figure 1 This is a block diagram illustrating the principle of the pain monitoring device in this invention.

[0035] Figure 2 This is a schematic diagram of the ultrasonic probe assembly structure in this invention.

[0036] Figure 3 This is a schematic diagram of the eye mask structure in this invention.

[0037] The components are: 1-eye shield, 101-through hole, 102-fixing strap, 2-ultrasound probe body, 3-probe accessories, 4-coupling agent injection hole, 5-data processor, 6-display, 7-data transmission line. Detailed Implementation

[0038] To enable those skilled in the art to better understand the technical solutions of the present invention, the technical solutions of the present invention will be further described below in conjunction with the accompanying drawings and embodiments.

[0039] See attached document Figure 1-3 The device shown is a perioperative pain monitoring device based on ultrasound technology, including an eye mask 1. The eye mask 1 has two through holes 101 at positions corresponding to the eyes. Each through hole 101 is equipped with an ultrasound probe assembly. The ultrasound probe assembly is used to collect ultrasound data from the patient's eyes. The eye mask 1 can fix the ultrasound probe assembly and also protect the patient's eyes.

[0040] Specifically, the ultrasound probe assembly includes an ultrasound probe body 2 and a probe accessory 3 located outside the ultrasound probe body 2. The probe accessory 3 is cap-shaped and can be made of flexible silicone. During use, it is attached to the patient's eyelid surface, with the ultrasound probe body 2 located inside the probe accessory 3. The probe accessory 3 has a coupling agent injection hole 4, through which coupling agent can be injected into the probe accessory 3, ensuring that there is no air between the ultrasound probe body 2 and the eyelid, thus preventing interference with ultrasound penetration and reducing acoustic impedance differences. The probe accessory 3 passes through a through-hole 101 on the eye mask 101, facilitating the injection of coupling agent into the probe accessory 3 through the coupling agent injection hole 4. The eye mask 1 also has an elastic fixing strap 102 for securing the eye mask 1 to the patient's head.

[0041] The monitoring device also includes a data processor 5 and a display 6. The data processor 5 is connected to the ultrasound probe body 2 via a data transmission line 7, which passes through the probe accessory 3. The ultrasound data collected by the ultrasound probe body 2 is transmitted to the data processor 5 via the data transmission line 7 for data processing, and the patient's pain level is analyzed based on the ultrasound data. The display 6 is communicatively connected to the data processor 5 and is used to display the data processed by the data processor 5.

[0042] The specific operating steps of the perioperative pain monitoring device based on ultrasound technology in this invention for monitoring patient pain include:

[0043] S1: Preparation for ultrasound scan;

[0044] Specifically, place the patient in a supine position, ensuring comfort and minimizing head movement. Prepare an eye mask 1, with two through holes 101 located above the patient's eyeballs. The inside of the eye mask 1 should fit snugly against the patient's skin to prevent movement, thereby improving measurement accuracy.

[0045] S2: Positioning and fixing of the ultrasonic probe assembly.

[0046] Specifically, the probe accessory 3 with the ultrasound probe body 2 is attached to the patient's eyelid, ensuring that the ultrasound probe body 2 is directly above the pupil; then, coupling agent is injected into the probe accessory 3 through the coupling agent injection hole 4 to eliminate the impedance difference when the sound wave propagates between the probe and the eyelid, ensuring the clarity and accuracy of the signal.

[0047] Finally, the goggles 1 are placed on top of the probe accessory 3, with the through hole 101 of the goggles 1 corresponding to the position of the probe accessory 3. The goggles 1 are then secured to the patient's head using the fixing strap 102 to ensure the stability of the ultrasound probe body 2 throughout the measurement process.

[0048] S3: Pupil ultrasound scan and data collection;

[0049] Specifically, the ultrasound probe body 2 emits ultrasound waves that penetrate the eyelid and reflect back, and the reflected signal is received by the ultrasound probe body 2; the ultrasound data collected by the ultrasound probe body 2 is transmitted to the data processor 5 through the data transmission line 7 to realize data acquisition.

[0050] S4: Data processing and pupil diameter measurement;

[0051] Specifically, after receiving the ultrasonic wave reflection signal, the data processor 5 analyzes the signal characteristics through a signal processing algorithm and calculates the pupil diameter. Utilizing the correlation between pupil diameter and pain level, and using a preset data model (the data processor 5 pre-sets a data model for the correlation between pupil diameter and pain level; this data model is an existing model and will not be elaborated upon in this invention), the pupil diameter data is converted into an assessment value for pain level.

[0052] More specifically, after receiving the ultrasonic wave reflection signal, the data processor 5 calculates the pupil diameter using the following steps:

[0053] (1) Signal processing and filtering: The data processor 5 performs signal processing on the received ultrasonic reflection signal, including filtering to remove noise and enhance the clarity of the signal.

[0054] (2) Signal analysis: Data processor 5 analyzes the characteristics of the processed signal, including signal strength, time delay, etc.

[0055] (3) Determine the pupil edge: Based on the signal characteristics obtained from step (2), the data processor 5 identifies the features related to the pupil edge in the reflected signal, such as changes in signal intensity or signal reflection characteristics at the edge, thereby determining the position of the pupil edge.

[0056] (4) Calculate the pupil diameter: After determining the position of the pupil's edge, the data processor 5 calculates the pupil's diameter. This is usually done by measuring the distance between the pupil's edges.

[0057] The correlation between pupil diameter and pain intensity is specifically expressed as follows: the higher the pain intensity experienced by the patient during the perioperative period (the greater the noxious stimulus), the larger the pupil diameter and the greater the rate of change in pupil diameter. Rate of change in pupil diameter (absolute value): Δ = |(T)| n -T0) / T0×100%│, where T0 is the patient's baseline pupil diameter, i.e., the diameter without painful stimulation; T n The pupil diameter is measured at any point during patient monitoring. When the patient experiences a noxious stimulus, T... n As the pupil diameter increases, the rate of change Δ of the pupil diameter also increases.

[0058] In addition, alarm thresholds can be set within the data processor 5, which will issue an alarm when the assessed level of pain reaches the threshold.

[0059] S5: Pain level data display and monitoring;

[0060] The monitor 6 displays the monitoring results (including pupil diameter, assessed pain level, and trends), allowing medical staff to view and analyze them in real time.

[0061] In addition, the display 6 allows medical staff to adjust the ultrasound data extraction frequency and set alarm thresholds as needed, so as to respond promptly to significant changes or rising trends in pain levels.

[0062] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The embodiments and descriptions in the specification are merely illustrative of the principles of the invention. Various changes and modifications can be made to the invention without departing from its spirit and scope, and all such changes and modifications fall within the scope of the present invention as claimed. The scope of protection of this invention is defined by the appended claims and their equivalents.

Claims

1. A perioperative pain monitoring device based on ultrasound technology, characterized in that: Includes an eye mask (1), on which two through holes (101) are opened at positions corresponding to the eyes, and each through hole (101) is provided with an ultrasonic probe assembly for collecting pupil ultrasonic data.

2. The perioperative pain monitoring device based on ultrasound technology according to claim 1, characterized in that: The ultrasonic probe assembly includes an ultrasonic probe body (2) and a probe accessory (3) located outside the ultrasonic probe body (2), and the probe accessory (3) has a coupling agent injection hole (4).

3. The perioperative pain monitoring device based on ultrasound technology according to claim 2, characterized in that: The monitoring device also includes a data processor (5) for processing ultrasound data and analyzing and assessing the degree of pain, the data processor (5) being connected to the ultrasound probe body (2) via a data transmission line (7).

4. The perioperative pain monitoring device based on ultrasound technology according to claim 3, characterized in that: The monitoring device also includes a display (6), which is connected to the data processor (5).

5. The perioperative pain monitoring device based on ultrasound technology according to claim 1, characterized in that: The goggles (1) are also provided with elastic fixing straps (102).

6. The monitoring method of the pain monitoring device as described in any one of claims 4 or 5, characterized in that, Includes the following steps, S1: Preparation for ultrasound scan; S2: Positioning and fixing of the ultrasonic probe assembly; S3: Pupil ultrasound scan and data collection; S4: Process and analyze the collected ultrasound data, converting it into pain level data; S5: Display and monitor the pain level data obtained in step S4 in real time.

7. The monitoring method according to claim 6, characterized in that, Step S2 includes the following steps: S201: Attach the probe accessory (3) with the ultrasound probe body (2) to the patient's eyelid, ensuring that the ultrasound probe body (2) is directly above the pupil; S202: Inject coupling agent into the probe accessory (3) through the coupling agent injection hole (4); S203: Cover the top of the probe accessory (3) with the goggles (1), with the through hole (101) of the goggles (1) corresponding to the position of the probe accessory (3), and fix the goggles (1) to the patient's head.

8. The monitoring method according to claim 6, characterized in that, Step S4 includes the following steps: S401: After receiving the ultrasonic reflection signal, the data processor (5) analyzes the signal characteristics through the signal processing algorithm and calculates the pupil diameter; S402: Utilize the correlation between pupil diameter and pain intensity to convert pupil diameter data into an assessment value for pain intensity.

9. The monitoring method according to claim 8, characterized in that, The specific operation of step S401 includes the following steps: S4011: The data processor (5) performs signal processing and filtering on the received ultrasonic reflection signal; S4012: Analyze the characteristics of the processed signal, including signal strength and time delay; S4013: Based on the signal characteristics, the data processor (5) identifies the features related to the pupil edge in the reflected signal and determines the position of the pupil edge; S4014: Calculate the pupil diameter based on the position of the pupil edge.

10. The monitoring method according to claim 8, characterized in that, In step S402, pupil diameter is positively correlated with pain intensity; the greater the rate of change in pupil diameter, the higher the pain intensity. The rate of change in pupil diameter Δ=│(T) n -T0) / T0×100%│, where T0 is the pupil diameter when the patient is not experiencing pain; T n The pupil diameter is measured at any point during the monitoring process.