A device and method for arteriovenous malformation response assessment

By employing highly sensitive patch structures and frequency-domain and time-domain analysis methods, the problem of non-invasive, continuous, dynamic, and quantitative assessment in the evaluation of arteriovenous malformation treatment has been solved, enabling non-invasive, painless, long-term dynamic monitoring and quantitative assessment.

CN120859449BActive Publication Date: 2026-01-09FUJIAN MATERNAL & CHILD HEALTH HOSPITAL
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Patent Information

Application Number
CN202511394703.1
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2025-09-28
Publication Date
2026-01-09
Estimated Expiration
2045-09-28

AI Technical Summary

Technical Problem

Existing technologies lack non-invasive, continuous, dynamic, and quantitative assessment methods for evaluating the treatment efficacy of arteriovenous malformations. Traditional methods suffer from problems such as invasiveness, high cost, strong operational dependence, and limited resolution.

Method used

A highly sensitive membrane structure is used to collect changes in micro-vibrations on the skin surface. Combined with frequency domain and time domain analysis methods, and through a light source, photodetector, optical circulator, detection device, microcontroller unit and terminal equipment, dynamic and objective evaluation of therapeutic effects can be achieved.

Benefits of technology

It enables non-invasive, painless, and long-term dynamic monitoring, quantifies hemodynamic parameters, provides objective efficacy assessment, and is suitable for long-term use.

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Abstract

The application provides an arteriovenous malformation curative effect evaluation device and method, which comprises a light source, a photodetector, an optical circulator, a detection device, a micro control unit and a terminal device; the light source is connected with the optical circulator through a first optical fiber, and the photodetector is connected with the optical circulator through a second optical fiber; the optical circulator is connected with the detection device through a third optical fiber; the photodetector is connected with the micro control unit, and the micro control unit is connected with the terminal device; the high-sensitivity diaphragm structure is used to collect the micro vibration changes of the skin surface, and the frequency domain and time domain analysis methods are combined to realize dynamic and objective evaluation of curative effect.
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Description

Technical Field

[0001] This invention relates to the field of biomedical engineering technology, and in particular to a device and method for evaluating the treatment efficacy of arteriovenous malformations. Background Technology

[0002] Arteriovenous malformations (AVMs) are a common type of congenital vascular developmental abnormality, frequently occurring in the head, face, and limbs. Because arteries and veins directly communicate in the affected area, bypassing the capillary bed, they easily create local circulatory disturbances characterized by high blood flow impact and uneven blood supply, manifesting as pulsating masses, elevated temperature, skin discoloration, and even bleeding. AVMs are characterized by their tendency to dilate, difficulty in complete cure, and high recurrence rate, often requiring multiple interventions during treatment.

[0003] In clinical practice, the assessment of AVM treatment efficacy primarily relies on imaging examinations. Current mainstream methods include digital subtraction angiography (DSA), magnetic resonance imaging (MRI), and color Doppler ultrasound (CDU). DSA is currently the gold standard for detection, dynamically displaying feeding arteries, draining veins, and lesion structures. However, the procedure is invasive, requiring the injection of contrast agents and exposure to radiation, making it unsuitable for frequent follow-up. MRI offers high tissue resolution but is costly, time-consuming, and only provides static information, making it difficult to assess postoperative changes in blood supply. CDU is suitable for initial screening and some postoperative monitoring, but it is highly operator-dependent, has limited resolution and data stability, and is difficult to standardize and quantify.

[0004] In recent years, some studies have attempted to apply flexible pressure sensors, impedance sensors, and optical sensing structures to the auxiliary monitoring of vascular malformations. For example, patent CN209122236U designed a hemangioma measuring ruler integrating a miniature wireless camera with a colorimetric bar, which can help determine the color and surface area changes of hemangiomas. However, it mainly relies on image processing and lacks real-time perception of functional parameters such as hemodynamics in the lesion area. In addition, patent CN109385475B proposed a method for assessment based on molecular biological indicators. Although it has high accuracy and scientific basis, it relies on tissue or cell samples and is an invasive detection method, making it unsuitable for continuous dynamic monitoring.

[0005] Therefore, in response to the urgent need for non-invasive, continuous, dynamic, and quantitative assessment methods in the treatment of AVM, a new auxiliary monitoring scheme for efficacy assessment is required. Summary of the Invention

[0006] In view of this, the purpose of the present invention is to provide a device and method for evaluating the efficacy of arteriovenous malformation treatment, which collects micro-vibration changes on the skin surface through a highly sensitive membrane structure and combines frequency domain and time domain analysis methods to achieve dynamic and objective evaluation of the efficacy.

[0007] To achieve the above objectives, the present invention adopts the following technical solution: a device for evaluating the treatment efficacy of arteriovenous malformations, comprising a light source 1, a photodetector 2, an optical circulator 3, a detection device 4, a microcontroller unit 5, and a terminal device 6; the light source 1 and the optical circulator 3 are connected via a first optical fiber 13, the photodetector 2 and the optical circulator 3 are connected via a second optical fiber 23; the optical circulator 3 and the detection device 4 are connected via a third optical fiber 34; the photodetector 2 is connected to the microcontroller unit 5, and the microcontroller unit 5 is connected to the terminal device 6;

[0008] The detection device 4 includes a sensor 43, a mechanical transmission component 44, and a sensitive diaphragm 45. The sensitive diaphragm 45 is disposed at the bottom of the detection device 4 and is used to collect the deformation of the skin surface caused by blood flow pulsation and pressure fluctuations. The light emitted by the light source 1 is transmitted to the optical circulator 3 through the first optical fiber 13 and then to the sensor 43 of the detection device 4. At the same time, the light signal returned from the detection device 4 is guided by the optical circulator 3 to the photodetector 2 and then converted into an electrical signal and sent to the microcontroller unit 5 for demodulation and analysis. The mechanical transmission component 44 is specifically a tapered structure at both ends. The lower end of the mechanical transmission component 44 is provided with a disc-shaped base and is fixedly connected to the middle of the sensitive diaphragm 45 by a curing agent. The upper end of the mechanical transmission component 44 is connected to the sensor 43 by dispensing or point contact.

[0009] In a preferred embodiment, the sensor 43 includes an interference cavity 431, a ceramic ferrule 432, and a sensing diaphragm 433. The sensing diaphragm 433 serves as one of the reflective surfaces of the interference cavity, senses external pressure or skin surface deformation, and converts the deformation into a nanometer-scale change in the length L of the interference cavity, which is reflected in the wavelength shift of the interference spectrum λ.

[0010] In a preferred embodiment, the light incident on the sensor 43 forms equal beam interference between the surface of the third optical fiber 34 and the sensing diaphragm 433, and as the sensing diaphragm 433 deforms, the optical path difference changes, resulting in a shift in the interference spectrum.

[0011] In a preferred embodiment, the detection device 4 further includes a flexible hose 41 and a housing 42.

[0012] In a preferred embodiment, the sensitive membrane 45 is in close contact with the area being measured.

[0013] In a preferred embodiment, according to the Fabry-Perot interference principle, the interference light intensity I is expressed as:

[0014]

[0015]

[0016] Here, L is the cavity length of the interference cavity, n is the refractive index of air, λ is the wavelength of the incident light, and R is the reflectivity of the diaphragm. π is an intermediate variable, representing the value of pi.

[0017] The relationship between the central deflection Y of the sensing diaphragm 433 and the external pressure P is given by the following formula.

[0018]

[0019] Where μ is the Poisson's ratio of the sensing diaphragm 433, and E is the elastic modulus of the sensing diaphragm 433. Let be the radius of the sensing diaphragm 433, and h be the thickness of the sensing diaphragm 433. When the sensing diaphragm 433 is subjected to external pressure, its central deflection Y will cause the length of the interference cavity L = L0 + Y to change, thereby modulating the output light intensity and causing a change in the output light intensity. L0 is the initial length of the interference cavity under no external pressure.

[0020] The present invention also provides a method for evaluating the treatment efficacy of arteriovenous malformations, wherein a device for evaluating the treatment efficacy of arteriovenous malformations performs the method, comprising the following steps:

[0021] Step S1: Signal acquisition; Fix the detection device 4 to the area of ​​the patient's arteriovenous malformation lesion, so that the sensitive membrane 45 is in close contact with the skin, and acquire the interference spectrum signal caused by blood flow pulsation on the skin surface through the light source 1, the optical circulator 3 and the sensor 43.

[0022] Step S2: Pre-treatment spectral baseline extraction; Before treatment, interference spectral signals of several consecutive cardiac cycles are collected, the main frequency and the spectral area corresponding to the main frequency are extracted, and the spectral areas corresponding to the second, third, and fourth frequencies are extracted respectively to form a preoperative spectral feature map.

[0023] Step S3: Post-treatment spectrum acquisition and feature extraction; After the patient receives treatment, the interference spectrum signal is repeatedly acquired at the same detection position, body position and conditions as before the treatment, and the main frequency and the corresponding spectral area are extracted, and the spectral areas corresponding to the second, third and fourth frequencies are extracted respectively to form a post-treatment spectrum feature map.

[0024] Step S4: Spectrum comparison analysis; Compare the spectrum characteristics before and after treatment, and analyze whether the proportion of the second, third, and fourth harmonic frequency areas to the main frequency area has decreased, thereby determining whether the hemodynamics of the lesion area has been improved.

[0025] Step S5: Calculate the efficacy index EI based on the results of step S4, and output the efficacy assessment results.

[0026] In a preferred embodiment, an intensity demodulation method is used to obtain the signal of reflected light intensity changing over time, and the time-domain signal is analyzed by Fast Fourier Transform (FFT) to obtain:

[0027] (1)

[0028] Here, S(f) represents the frequency domain signal, i.e. the light intensity distribution at different frequencies, and I(t) represents the signal of the reflected light intensity output by the detection device changing with time; f is a frequency variable, and its main frequency f0 corresponds to the arterial pulsation frequency of the target site. is a complex exponential kernel function used to transform time-domain signals into frequency-domain signals; t is a time variable; the spectral areas corresponding to the main frequency f0, second harmonic frequency f2, third harmonic frequency f3, and fourth harmonic frequency f4 are extracted through frequency domain analysis and denoted as S1, S2, S3, and S4 respectively, and the area ratio is calculated.

[0029] (2)

[0030] (3)

[0031] (4)

[0032] (5)

[0033] Where Δf is the bandwidth of the integral frequency band, which is determined by the system resolution or half-power bandwidth.

[0034] In a preferred embodiment, the efficacy index EI is calculated using the following formula:

[0035] (6)

[0036] Where ω1, ω2, and ω3 are weighting coefficients;

[0037] Calculate the pre-treatment efficacy index (EI) separately. pre and the efficacy index (EI) after treatment post :

[0038] (7)

[0039] (8)

[0040] in, , , , These are the spectral areas corresponding to the main frequency, second harmonic frequency, third harmonic frequency, and fourth harmonic frequency before treatment, respectively. , , , These are the spectral areas corresponding to the main frequency, second harmonic frequency, third harmonic frequency, and fourth harmonic frequency after treatment, respectively.

[0041] If the EI is calculated after treatment post The value was significantly lower than the pre-treatment EI. pre A positive EI value indicates an increase in the proportion of the dominant frequency signal, a decrease in higher-order harmonic components, and a tendency towards hemodynamic stability, indicating a good therapeutic effect; conversely, a negative EI value after treatment indicates a poor therapeutic effect. post If the value does not decrease, or still shows an excessively high proportion of higher-order harmonics and a disordered spectral structure, it indicates that hemodynamics have not returned to normal and the therapeutic effect is poor.

[0042] Compared with the prior art, the present invention has the following beneficial effects:

[0043] 1. Non-invasive, painless, and suitable for long-term dynamic monitoring.

[0044] 2. The sensing element is made of optical fiber, which is small in size and allows for more precise detection of the detection area.

[0045] 3. The system can quantify hemodynamic parameters and objectively standardize them. Attached Figure Description

[0046] Figure 1 This is a schematic diagram of the usage state of a device for evaluating the treatment efficacy of arteriovenous malformations according to a preferred embodiment of the present invention;

[0047] Figure 2 This is a schematic diagram of the detection device structure according to a preferred embodiment of the present invention;

[0048] Figure 3 This is a schematic diagram of the sensor structure according to a preferred embodiment of the present invention. Detailed Implementation

[0049] The present invention will be further described below with reference to the accompanying drawings and embodiments.

[0050] It should be noted that the following detailed descriptions are illustrative and intended to provide further explanation of this application. Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains.

[0051] It should be noted that the terminology used herein is for the purpose of describing particular implementations only and is not intended to limit the exemplary implementations according to this application; as used herein, the singular form is intended to include the plural form as well, unless the context clearly indicates otherwise; furthermore, it should be understood that when the terms “comprising” and / or “including” are used in this specification, they indicate the presence of features, steps, operations, devices, components and / or combinations thereof.

[0052] A device for evaluating the treatment efficacy of arteriovenous malformations, reference Figure 1-3 The system includes a light source 1, a photodetector 2, an optical circulator 3, a detection device 4, a microcontroller 5, and a terminal device 6. The light source 1 and the optical circulator 3 are connected via a first optical fiber 13, and the photodetector 2 and the optical circulator 3 are connected via a second optical fiber 23. The optical circulator 3 and the detection device 4 are connected via a third optical fiber 34. The photodetector 2 is connected to the microcontroller 5, and the microcontroller 5 is connected to the terminal device 6. The light source 1 is specifically a laser or a light-emitting diode, used to provide the required incident light. The optical circulator 3 is used to achieve unidirectional transmission of the optical path. The laser emitted by the light source 1 is transmitted to the detection device 4 via the optical circulator 3. The returned interference signal is converted into a time-domain electrical signal by the photodetector 2 and input to the microcontroller 5. The microcontroller 5 first preprocesses the time-domain electrical signal (DC removal, filtering, noise suppression), and then performs a Fast Fourier Transform (FFT) to obtain the frequency-domain signal. The microcontroller 5 has a built-in Bluetooth module to wirelessly transmit the processed data to the terminal device 6. The terminal device 6 is used to display real-time waveforms, analysis results, and generate a detection report.

[0053] Figure 2 This is a schematic diagram of the detection device 4, which is cylindrical in shape. The detection device 4 includes a sensor 43, a mechanical transmission assembly 44, and a sensitive membrane 45. The sensitive membrane 45 is located at the bottom of the detection device 4, with an outer diameter of approximately 5 mm and a thickness of approximately 50–80 μm. It is used to collect minute deformations on the skin surface caused by blood flow pulsation and pressure fluctuations. The sensitive membrane 45 is made of medical-grade silicone material to ensure a soft fit with the skin and sufficient sensitivity. Light emitted from the light source 1 is transmitted through the first optical fiber 13 to the optical circulator 3 and then from the optical circulator 3 to the sensor 43 of the detection device 4. Simultaneously, the light signal returned from the detection device 4 is guided through the optical circulator 3 to the photodetector 2 and converted into an electrical signal, which is then sent to the microcontroller unit 5 for demodulation and analysis. The detection device 4 also includes an elastic tube 41 and a housing 42. The housing 42 is made of medical-grade stainless steel with a wall thickness of approximately 0.5–1 mm to ensure sufficient mechanical strength and good biocompatibility.

[0054] Specifically, the detection device 4 has an outer diameter of approximately 18-20 mm, a thickness of approximately 8-10 mm, and an overall weight of no more than 30 g, making it suitable for long-term wear on the face, limbs, and other areas. The sensitive diaphragm 45 has a diameter of approximately 5 mm and a thickness of approximately 50–80 μm; the sensor 43 is specifically a diaphragm-type fiber optic Fabry-Perot sensor, with an overall length of approximately 10–12 mm; the mechanical transmission assembly 44 has a length of approximately 4–6 mm, a lower base diameter of approximately 4–5 mm, and a tapered end diameter of approximately 2–2.5 mm.

[0055] The mechanical transmission component 44 is specifically a tapered structure at both ends, made of medical-grade stainless steel. A disc-shaped base is provided at the lower end of the mechanical transmission component 44, which is fixedly connected to the middle of the sensitive membrane 45 using a curing agent. The upper end of the mechanical transmission component 44 is connected to the sensor 43 via dispensing or point contact. The mechanical transmission component 44 achieves efficient dimensional transition and pressure transmission between the sensitive membrane 45 and the sensor 43, facilitating high-fidelity transmission of signals from the skin surface to the sensing membrane 433 of the FP sensor.

[0056] The sensor 43 includes an interference cavity 431, a ceramic ferrule 432, and a sensing diaphragm 433. The sensing diaphragm 433, as one of the reflective surfaces of the interference cavity, senses external pressure or skin surface deformation and converts the deformation into a nanometer-scale change in the interference cavity length L, reflected in the wavelength shift of the interference spectrum λ. The laser signal emitted by the light source 1 is transmitted to the optical circulator 3 via the first optical fiber 13, and then transmitted by the optical circulator 3 to the sensor 43 of the detection device 4. The reflected light signal returned by the detection device is guided by the optical circulator 3 to the photodetector 2, achieving unidirectional signal transmission and separation, avoiding optical path interference. Specifically, the length of the interference cavity 431 is approximately 300-500 μm, and the thickness of the sensing diaphragm 433 is approximately 10-20 μm, ensuring high sensitivity and flexibility. The ceramic ferrule 432 has a length of 10 mm, an outer diameter of 2.5 mm, and an inner diameter of 1.26 mm. The single-mode fiber is a standard single-mode fiber with a diameter of 9 μm; in addition, all input and output fibers are standard single-mode communication fibers. With a fiber diameter of less than 250 μm and a fine overall probe size, it can achieve high-resolution detection of local lesions, avoiding the signal averaging phenomenon caused by the excessively large detection area of ​​traditional sensors.

[0057] When the skin in the lesion area undergoes a slight deformation due to blood flow pulsation or changes in local pressure, the sensitive diaphragm 45 vibrates slightly in sync. This vibration directly drives the sensing diaphragm 433 of the sensor 43 to deform via the mechanical transmission component 44, thereby causing a change in the length of the interference cavity 431. The final output interference spectrum experiences wavelength shift, and the original detection data can be obtained through demodulation.

[0058] The light incident on sensor 43 forms equal-beam interference between the surface of the third optical fiber 34 and the sensing diaphragm 433. As the sensing diaphragm 433 deforms, the optical path difference changes, causing a shift in the interference spectrum. The reflected light returns through the third optical fiber 34 and is transmitted to the photodetector 2 via the optical circulator 3 for subsequent demodulation and analysis.

[0059] During use, the diaphragm-type fiber optic Fabry-Perot sensor collects micro-vibration signals on the skin surface, reflecting the deformation changes in the lesion area caused by blood flow pulsation. The interference signal is converted into an electrical signal by the photodetector 2 and sent to the microcontroller unit 5 for demodulation and analysis. After passing through the signal processing module, a hemodynamic change model is constructed by combining frequency domain analysis (dominant frequency, harmonic energy distribution) and time domain analysis (peak amplitude, fluctuation rate, etc.).

[0060] To improve the accuracy of signal extraction, this system also integrates adaptive filtering and feature extraction algorithms, which can effectively suppress non-target interference factors such as respiration and body movement, achieving high-precision reconstruction of lesion pulsation signals. The system supports data comparison between different time periods to construct an individualized efficacy scoring model, thereby enabling quantitative assessment of treatment response trends.

[0061] Specifically, the sensitive membrane 45 is in close contact with the arteriovenous malformation site 8 on the surface of human skin 7.

[0062] Specifically, according to the Fabry-Perot interference principle, the interference intensity I is expressed as:

[0063]

[0064]

[0065] Here, L is the cavity length of the interference cavity, n is the refractive index of air, λ is the wavelength of the incident light, and R is the reflectivity of the diaphragm. π is an intermediate variable, representing the value of pi.

[0066] The relationship between the central deflection Y of the sensing diaphragm 433 and the external pressure P is given by the following formula.

[0067]

[0068] Where μ is the Poisson's ratio of the sensing diaphragm 433, and E is the elastic modulus of the sensing diaphragm 433. Let be the radius of the sensing diaphragm 433, and h be the thickness of the sensing diaphragm 433. When the sensing diaphragm 433 is subjected to external pressure, its central deflection Y will cause the length of the interference cavity L=L0+Y to change, thereby modulating the output light intensity and causing a change in the output light intensity.

[0069] A method for evaluating the treatment efficacy of arteriovenous malformations, employing the aforementioned device for evaluating the treatment efficacy of arteriovenous malformations, includes the following steps:

[0070] Step S1: Signal acquisition; Fix the detection device 4 to the area of ​​the patient's arteriovenous malformation lesion, so that the sensitive membrane 45 is in close contact with the skin, and acquire the interference spectrum signal caused by blood flow pulsation on the skin surface through the light source 1, the optical circulator 3 and the sensor 43.

[0071] Step S2: Pre-treatment spectral baseline extraction; Before treatment, interference spectral signals of several consecutive cardiac cycles are collected, the main frequency and the spectral area corresponding to the main frequency are extracted, and the spectral areas corresponding to the second, third, and fourth frequencies are extracted respectively to form a pre-treatment spectral feature map.

[0072] Step S3: Post-treatment spectrum acquisition and feature extraction; After the patient receives treatment, the interference spectrum signal is repeatedly acquired at the same detection position, body position and conditions as before the treatment, and the main frequency and the corresponding spectral area are extracted, and the spectral areas corresponding to the second, third and fourth frequencies are extracted respectively to form a post-treatment spectrum feature map.

[0073] Step S4: Spectrum comparison analysis; Compare the spectrum characteristics before and after treatment, and analyze whether the proportion of the second, third, and fourth harmonic frequency areas to the main frequency area has decreased, thereby determining whether the hemodynamics of the lesion area has been improved.

[0074] Step S5: Calculate the efficacy index EI based on the results of step S4, and output the efficacy assessment results.

[0075] In a preferred embodiment, an intensity demodulation method is used to obtain the signal of reflected light intensity changing over time, and the time-domain signal is analyzed by Fast Fourier Transform (FFT) to obtain:

[0076] (1)

[0077] Here, S(f) represents the frequency domain signal, i.e. the light intensity distribution at different frequencies, and I(t) represents the signal of the reflected light intensity output by the detection device changing with time; f is a frequency variable, and its main frequency f0 corresponds to the arterial pulsation frequency of the target site. is a complex exponential kernel function used to transform time-domain signals into frequency-domain signals; t is a time variable; the spectral areas corresponding to the main frequency f0, second harmonic frequency f2, third harmonic frequency f3, and fourth harmonic frequency f4 are extracted through frequency domain analysis and denoted as S1, S2, S3, and S4 respectively, and the area ratio is calculated.

[0078] (2)

[0079] (3)

[0080] (4)

[0081] (5)

[0082] Where Δf is the bandwidth of the integral frequency band, which is determined by the system resolution or half-power bandwidth.

[0083] The formula for calculating the efficacy index (EI) is as follows:

[0084] (6)

[0085] In this study, ω1, ω2, and ω3 are weighting coefficients. These coefficients were established by collecting spectral data from multiple patients with arteriovenous malformations before and after treatment, while simultaneously recording efficacy evaluations (such as physician scores and imaging assessments) before and after treatment. The correlation between the area ratios of each harmonic and the actual therapeutic effect was then established. Finally, statistical analysis methods were used to determine the weighting coefficients for each harmonic. This method ensures that the weighting coefficients are supported by clear medical data, avoids subjective arbitrariness, and improves the accuracy and clinical application value of the efficacy index (EI).

[0086] Calculate the pre-treatment efficacy index (EI) separately. pre and the efficacy index (EI) after treatment post :

[0087] (7)

[0088] (8)

[0089] in, , , , These are the spectral areas corresponding to the main frequency, second harmonic frequency, third harmonic frequency, and fourth harmonic frequency before treatment, respectively. , , , These are the spectral areas corresponding to the main frequency, second harmonic frequency, third harmonic frequency, and fourth harmonic frequency after treatment, respectively.

[0090] If the EI is calculated after treatment post The value was significantly lower than the pre-treatment EI. pre A positive EI value indicates an increase in the proportion of the dominant frequency signal, a decrease in higher-order harmonic components, and a tendency towards hemodynamic stability, indicating a good therapeutic effect; conversely, a negative EI value after treatment indicates a poor therapeutic effect. postIf the value does not decrease, or still shows an excessively high proportion of higher-order harmonics and a disordered spectral structure, it indicates that hemodynamics have not returned to normal and the therapeutic effect is poor.

[0091] In a practical application, the microcontroller unit 5 collects and analyzes spectral data of the patient before and after treatment, obtaining the following area ratio:

[0092] Before treatment: ;

[0093] Post-treatment: .

[0094] Substituting the weights ω1=0.4, ω2=0.35, and ω3=0.25, calculate the efficacy index (EI):

[0095] (9)

[0096] Substituting the data, we get:

[0097] EI pre =0.4×0.324+0.35×0.212+0.25×0.162=0.244

[0098] (10)

[0099] Substituting the data, we get:

[0100] EI post =0.4×0.139+0.35×0.096+0.25×0.07=0.107

[0101] The final EI value was 0.244 before treatment and 0.107 after treatment, indicating that the proportion of higher-order harmonics area decreased significantly and the spectral structure tended to be concentrated, indicating that the treatment was effective.

[0102] In clinical applications, signals from the lesion site acquired before treatment can be used as a baseline to extract parameters such as the dominant frequency, harmonic ratio, and amplitude. After treatment, signals are acquired again at the same detection point and under the same conditions, and the same parameters are extracted. By comparing the changes in spectral characteristics before and after treatment (such as stable changes in dominant frequency, decrease in harmonic ratio, and reduction in amplitude), the efficacy index can be calculated, enabling objective evaluation and dynamic tracking of treatment effects.

Claims

1. A device for evaluating the treatment efficacy of arteriovenous malformations, characterized in that, The device includes a light source (1), a photodetector (2), an optical circulator (3), a detection device (4), a microcontroller unit (5), and a terminal device (6); the light source (1) and the optical circulator (3) are connected through a first optical fiber (13), the photodetector (2) and the optical circulator (3) are connected through a second optical fiber (23); the optical circulator (3) and the detection device (4) are connected through a third optical fiber (34); the photodetector (2) is connected to the microcontroller unit (5), and the microcontroller unit (5) is connected to the terminal device (6); The detection device (4) includes a sensor (43), a mechanical transmission component (44), and a sensitive diaphragm (45). The sensitive diaphragm (45) is located at the bottom of the detection device (4) and is used to collect the deformation of the skin surface caused by blood flow pulsation and pressure fluctuation. The light emitted by the light source (1) is transmitted to the optical circulator (3) through the first optical fiber (13) and then transmitted to the sensor (43) of the detection device (4) by the optical circulator (3). At the same time, the light signal returned from the detection device (4) is guided to the photodetector (2) through the optical circulator (3) and then converted into an electrical signal and sent to the microcontroller unit (5) for demodulation and analysis. The mechanical transmission component (44) is specifically a tapered structure at both ends. The lower end of the mechanical transmission component (44) is provided with a disc-shaped base, which is fixedly connected to the middle of the sensitive diaphragm (45) by a curing agent. The upper end of the mechanical transmission component (44) is connected to the sensor (43) by dispensing or point contact. The formula for calculating the efficacy index (EI) is as follows: (6) Where ω1, ω2, and ω3 are weighting coefficients; Calculate the pre-treatment efficacy index (EI) separately. pre and the efficacy index (EI) after treatment post : (7) (8) in, , , , These are the spectral areas corresponding to the main frequency, second harmonic frequency, third harmonic frequency, and fourth harmonic frequency before treatment, respectively. , , , These are the spectral areas corresponding to the main frequency, second harmonic frequency, third harmonic frequency, and fourth harmonic frequency after treatment, respectively. If the EI is calculated after treatment post The value was significantly lower than the pre-treatment EI. pre A positive EI value indicates an increase in the proportion of the dominant frequency signal, a decrease in higher-order harmonic components, and a tendency towards hemodynamic stability, indicating a good therapeutic effect; conversely, a negative EI value after treatment indicates a poor therapeutic effect. post If the value does not decrease, or still shows an excessively high proportion of higher-order harmonics and a disordered spectral structure, it indicates that hemodynamics have not returned to normal and the therapeutic effect is poor.

2. The device for evaluating the treatment efficacy of arteriovenous malformations according to claim 1, characterized in that, The sensor (43) includes an interference cavity (431), a ceramic ferrule (432), and a sensing diaphragm (433). The sensing diaphragm (433) serves as one of the reflective surfaces of the interference cavity, senses external pressure or skin surface deformation, and converts the deformation into a nanometer-scale change in the length L of the interference cavity, which is reflected in the wavelength shift of the interference spectrum λ.

3. The device for evaluating the treatment efficacy of arteriovenous malformations according to claim 2, characterized in that, The light incident on the sensor (43) forms equal beam interference between the surface of the third optical fiber (34) and the sensing diaphragm (433), and changes in optical path difference as the sensing diaphragm (433) deforms, resulting in a drift in the interference spectrum.

4. The device for evaluating the treatment efficacy of arteriovenous malformations according to claim 1, characterized in that, The detection device (4) also includes a flexible hose (41) and a housing (42).

5. The device for evaluating the treatment efficacy of arteriovenous malformations according to claim 1, characterized in that, The sensitive membrane (45) is in close contact with the part being tested.

6. The device for evaluating the treatment efficacy of arteriovenous malformations according to claim 1, characterized in that, According to the Fabry-Perot interference principle, the interference light intensity I is expressed as: Here, L is the cavity length of the interference cavity, n is the refractive index of air, λ is the wavelength of the incident light, and R is the reflectivity of the diaphragm. π is an intermediate variable, representing the value of pi. The relationship between the central deflection Y of the sensing diaphragm (433) and the external pressure P is given by the following formula. Where μ is the Poisson's ratio of the sensing diaphragm (433), and E is the elastic modulus of the sensing diaphragm (433). Let be the radius of the sensing diaphragm (433), and h be the thickness of the sensing diaphragm (433). When the sensing diaphragm (433) is subjected to external pressure, its central deflection Y will cause the length of the interference cavity L = L0 + Y to change, thereby modulating the output light intensity and causing the output light intensity to change. L0 is the initial length of the interference cavity under no external pressure.

7. A device for evaluating the treatment efficacy of arteriovenous malformations according to any one of claims 1-6, characterized in that, This device is used to perform a method for evaluating the treatment efficacy of arteriovenous malformations, including the following steps: Step S1: Signal acquisition; Fix the detection device (4) to the area of ​​the patient's arteriovenous malformation lesion, so that the sensitive membrane (45) is in close contact with the skin, and acquire the interference spectrum signal caused by blood flow pulsation on the skin surface through the light source (1), optical circulator (3) and sensor (43); Step S2: Pre-treatment spectral baseline extraction; Before treatment, interference spectral signals of several consecutive cardiac cycles are collected, the main frequency and the spectral area corresponding to the main frequency are extracted, and the spectral areas corresponding to the second, third, and fourth frequencies are extracted respectively to form a preoperative spectral feature map. Step S3: Post-treatment spectrum acquisition and feature extraction; After the patient receives treatment, the interference spectrum signal is repeatedly acquired at the same detection position, body position and conditions as before the treatment, and the main frequency and the corresponding spectral area are extracted, and the spectral areas corresponding to the second, third and fourth frequencies are extracted respectively to form a post-treatment spectrum feature map. Step S4: Spectrum comparison analysis; Compare the spectrum characteristics before and after treatment, and analyze whether the proportion of the second, third, and fourth harmonic frequency areas to the main frequency area has decreased, thereby determining whether the hemodynamics of the lesion area has been improved. Step S5: Calculate the efficacy index EI based on the results of step S4, and output the efficacy assessment results.

8. The device for evaluating the treatment efficacy of arteriovenous malformations according to claim 7, characterized in that, The intensity-modulated signal of reflected light intensity over time was obtained, and the time-domain signal was analyzed by Fast Fourier Transform (FFT) to obtain the following results: (1) Here, S(f) represents the frequency domain signal, i.e. the light intensity distribution at different frequencies, and I(t) represents the signal of the reflected light intensity output by the detection device changing with time; f is a frequency variable, and its main frequency f0 corresponds to the arterial pulsation frequency of the target site. is a complex exponential kernel function used to transform time-domain signals into frequency-domain signals; t is a time variable; the spectral areas corresponding to the main frequency f0, second harmonic frequency f2, third harmonic frequency f3, and fourth harmonic frequency f4 are extracted through frequency domain analysis and denoted as S1, S2, S3, and S4 respectively, and the area ratio is calculated. (2) (3) (4) (5) Where Δf is the bandwidth of the integral frequency band, which is determined by the system resolution or half-power bandwidth.

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