Instrument and method for identifying lymphedema condition after breast cancer operation

Abstract

The invention provides a breast cancer postoperative lymphedema condition identification apparatus and method. The system comprises a main console, an integrated measuring arm sleeve, a dimension measuring module and a bioelectrical impedance measuring module; the integrated measuring arm sleeve comprises a measuring cavity used for containing a limb to be measured and a structural layer located outside the measuring cavity, the dimension measuring module comprises a plurality of dimension measuring pieces arranged in the structural layer, and the bioelectrical impedance measuring module comprises at least two pairs of electrodes arranged on the inner side wall of the measuring cavity. The dimension measuring pieces and the electrodes are arranged at intervals in the axial direction of the limb and are electrically connected with the main console; the dimension measurement module is used for acquiring the circumference information of a limb to be measured in a non-invasive manner, and the bioelectrical impedance measurement module is used for applying an excitation signal to the limb to be measured and detecting impedance response. According to the method, rapid, objective and repeatable evaluation of lymphedema is realized, and the problems of single data dimension, non-uniform measurement basis, insensitive early edema identification and the like in the prior art are solved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of postoperative identification, in particular to a breast cancer postoperative lymphedema identification device and method. BACKGROUND

[0002] Breast cancer-related lymphedema (BCRL) is a common chronic complication after breast cancer surgery, mainly caused by axillary lymph node dissection or radiotherapy leading to structural damage or dysfunction of the lymphatic system, resulting in abnormal accumulation of protein-rich lymph fluid in the interstitial space. Accurate assessment is crucial for early intervention, efficacy monitoring and improving patient quality of life.

[0003] Current clinical assessment methods have limitations: 1. Manual tape circumference measurement: simple method but highly subjective, measurement site, technique and tightness are difficult to standardize, with poor reproducibility, and cannot distinguish between edema and fat or muscle tissue changes.

[0004] 2. Water displacement method for volume measurement: considered the gold standard for volume measurement, but the operation is complicated and time-consuming, and is not suitable for patients with open wounds or infections.

[0005] 3. Bioelectrical impedance analysis (BIA): can non-invasively assess tissue fluid composition, but existing commercial body composition analyzers are not designed specifically for unilateral limb lymphedema, and electrode placement and algorithms lack specificity.

[0006] 4. Imaging examination: such as ultrasonography (USG), magnetic resonance imaging (MRI), can provide detailed structural information, but the equipment is expensive, the operation depends on the technician, and the examination time is long, not suitable for bedside rapid screening and long-term dynamic monitoring.

[0007] Therefore, there is an urgent need in the clinic for a device that can integrate standardized morphological measurement and specific component analysis to achieve rapid, objective and repeatable bedside assessment to overcome the limitations of existing technology in measuring a single dimension, inconsistent standards and inability to early and sensitive identify fluid accumulation. SUMMARY

[0008] To solve the above problems of the prior art, the present application provides a breast cancer postoperative lymphedema identification device and method, which realizes rapid, objective and repeatable assessment of lymphedema.

[0009] To achieve the above purpose, the technical scheme adopted by the present application is: In a first aspect, the present application provides a breast cancer postoperative lymphedema identification device, comprising a main console, an integrated measurement arm sleeve, a dimension measurement module and a bioelectrical impedance measurement module. The integrated measurement arm sleeve comprises a measurement cavity for accommodating a measured limb and a structural layer located outside the measurement cavity, the dimension measurement module comprises a plurality of dimension measurement pieces arranged in the structural layer, and the bioelectrical impedance measurement module comprises at least two pairs of electrodes arranged on the inner side wall of the measurement cavity, the dimension measurement pieces and the electrodes are arranged at intervals along the limb axis, and are electrically connected to the main console. The dimension measurement module is used for non-invasively obtaining the circumference information of the measured limb, and the bioelectrical impedance measurement module is used for applying an excitation signal to the measured limb and detecting an impedance response.

[0010] The present application has the beneficial effects that: by integrating the dimension measurement module and the bioelectrical impedance measurement module in the same measurement arm sleeve and realizing data synchronous acquisition and fusion processing through the main control unit, the morphological parameters and tissue composition parameters of the limb can be obtained at the same time in a single measurement, thereby realizing rapid, objective and repeatable evaluation of lymphedema, and overcoming the problems of single data dimension, non-uniform measurement reference and insensitive early edema identification in the prior art.

[0011] Optionally, a data processing module is arranged in the main console, and the data processing module is used for: calculating the volume parameter of the limb based on the circumference information; calculating the limb feature parameter based on the impedance response; fusing the volume parameter and the limb feature parameter to generate a comprehensive evaluation result of lymphedema.

[0012] Optionally, the dimension measurement piece is a pressure sensing ring belt, which contains a micro pressure sensor array, a micro air pump is arranged in the main console, the micro air pump is communicated with the measurement cavity through a pipeline, and is used for inflating the measurement cavity to make the arm sleeve fit the limb.

[0013] Optionally, the pressure sensing ring belt is arranged on a preset axial standardized site determined based on the bony landmarks of the limb; the standardized site includes: 10 cm proximal to the radial styloid, 5 cm distal to the olecranon and 10 cm proximal to the olecranon.

[0014] According to the above description, by explicitly limiting the standardized site to the standardized axial position defined based on the bony landmarks, the consistency and comparability of each measurement in anatomy are ensured, the error caused by the drift of the site in manual measurement is overcome, and the longitudinal follow-up data has higher clinical reliability.

[0015] Optionally, the dimension measurement module acquires the circumference information includes the following steps: Filling constant low pressure gas into the structure layer, so that the structure layer uniformly adheres to the surface of the measured limb; Collecting the circumferential pressure distribution P(θ) through the pressure sensor array of all pressure sensing rings; Based on the pre-calibrated pressure-deformation model, reconstructing the approximate geometric profile of each section, the pressure-deformation model is expressed as: R(θ)=R0+α (P(θ)-P avg ) / P avg ; Wherein, R(θ) is the radial distance at angle θ, R0 is the initial fitting radius, α is the material deformation coefficient, P(θ) is the pressure value at angle θ, P avg is the average pressure of the section; Based on the reconstructed profile point set {R(θ i )}, calculate the polygon perimeter to obtain the circumference information C i of each standardized site, the calculation process of the circumference information C i is: ; Wherein, N is the number of pressure sensors; The data processing module is used to calculate the volume parameter of the limb based on the circumference information includes: Combined with the distance of each standardized site, the segmented trapezoidal integral method is used to calculate the total volume V of the limb.

[0016] Optionally, the calculation formula of the segmented trapezoidal integral method is: V≈(L B -L A )×(C A ²+C B ²) / (8π)+(L C -L B )×(C B ²+C C ²) / (8π); Wherein, C A , C B , C C are the circumference values of the three standardized sites, L A , L B and L C are the distances of the three standardized sites from the radial styloid process.

[0017] As described above, a complete and automated quantitative process has been achieved, from circumference measurement at multiple standardized sites to calculation of total limb volume. This ensures the consistency and repeatability of the volume calculation results, providing high-precision and high-efficiency morphological quantitative evidence for subsequent calculation of volume change rate and long-term dynamic monitoring of therapeutic effects.

[0018] Optionally, the limb characteristic parameter is the extracellular fluid resistivity ratio R. ratio And the phase angle PA, the data processing module for calculating limb characteristic parameters based on the impedance response includes: Calculate the complex impedance Z at each frequency. raw (f): Z raw (f)=R raw (f)+jX raw (f); In the formula, R raw (f) represents the resistance component, X raw (f) represents the reactance component, and j is the imaginary unit; Extract the resistivity component at 5 kHz and calculate the extracellular fluid resistivity ratio R. ratio : R ratio =R ea / R eh ; In the formula, R ea R is the baseline resistance value of the limb under test at 5kHz. eh The baseline resistance value of the unaffected limb at 5kHz; Extract the resistance component R at 50kHz. raw (50kHz) and reactance component X raw (f) Calculate the phase angle PA: PA = arctan(X) raw (50kHz) / R raw (50kHz)) (180 / π).

[0019] As described above, by extracting the 5kHz low-frequency resistance to calculate the extracellular fluid resistance ratio and simultaneously calculating the 50kHz phase angle, the bioelectrical impedance measurement module can directly and quantitatively reflect the difference in tissue fluid volume and tissue health between the affected and healthy sides, improving the sensitivity of early edema and helping to distinguish the high protein fluid accumulation unique to lymphedema.

[0020] Optionally, the data processing module is further configured to: Impedance data at multiple frequencies are fitted to a Cole-Cole model using a nonlinear least squares method. The complex impedance Z(ω) of the Cole-Cole model is expressed as: Z(ω)=R ∞ +(R0-R ∞ ) / [1+(jωτ) α ]; ω = 2πf; In the formula, R0 is the zero-frequency resistance, R ∞ For an infinite frequency resistor, j is the imaginary unit, ω is the angular frequency, f is the measurement frequency, τ is the relaxation time constant, and α is the distribution coefficient; Based on the fitted parameters R0 and R ∞ Calculate the extracellular water ratio (ECF R). ratio : ECF R ratio =R0 / R ∞ .

[0021] As described above, by fitting multi-frequency impedance data to the Cole-Cole model and analytically determining the zero-frequency resistance R0 and the infinite-frequency resistance R... ∞ It can calculate the extracellular water ratio that is not affected by individual tissue structure differences, thus providing a more stable and specific indicator of the relative proportion of extracellular fluid, enhancing the analytical accuracy and interpretability under micro-variable monitoring and complex tissue conditions.

[0022] Optionally, the main control console is used to display circumference information, volume parameters and limb characteristic parameters, as well as the volume change rate and exponential change rate compared with the healthy side data; The comprehensive evaluation result is generated based on a preset edema judgment standard, and is obtained by fusing the circumference information, the volume parameters, and the limb characteristic parameters.

[0023] Secondly, the present invention provides a method for identifying postoperative lymphedema in breast cancer patients, comprising the following steps: The patient sits down and places the affected limb to be tested into the measuring cavity of the integrated measuring arm sleeve; The circumference information of the limb under test is obtained non-invasively through multiple dimensional measuring devices using the dimensional measurement module. The bioelectrical impedance measurement module applies an excitation signal to the limb under test and detects the impedance response by using at least two pairs of electrodes. Based on the circumference information and the impedance response, a comprehensive assessment result of lymphedema is generated.

[0024] The technical effects of the method for identifying postoperative lymphedema in breast cancer provided in the second aspect are described in the relevant description of the instrument for identifying postoperative lymphedema in breast cancer provided in the first aspect. Attached Figure Description

[0025] Figure 1 Fig. 1 is a structural schematic diagram of a breast cancer postoperative lymphedema identification apparatus according to an embodiment of the present application; Figure 2 Fig. 2 is a main flow schematic diagram of a breast cancer postoperative lymphedema identification method according to an embodiment of the present application.

[0026] Legend of reference signs: 1, main control console; 2, integrated measurement arm sleeve; 21, measurement cavity; 22, structural layer; 3, dimension measurement module; 4, bioelectrical impedance measurement module. DETAILED DESCRIPTION

[0027] In order to better understand the above technical solutions, the exemplary embodiments of the present application will be described in more detail below with reference to the accompanying drawings. Although the exemplary embodiments of the present application are shown in the drawings, it should be understood that the present application can be implemented in various forms and should not be limited by the embodiments described herein. On the contrary, these embodiments are provided so that the present application can be more clearly, thoroughly understood and the scope of the present application can be completely conveyed to those skilled in the art.

[0028] Embodiment one Please refer to Figure 1 A breast cancer postoperative lymphedema identification apparatus suitable for clinical rapid testing, which comprises a main control console 1, an integrated measurement arm sleeve 2, a dimension measurement module 3 and a bioelectrical impedance measurement module 4. The integrated measurement arm sleeve 2 comprises a measurement cavity 21 for accommodating a measured limb and a structural layer 22 located outside the measurement cavity 21. The dimension measurement module 3 comprises a plurality of dimension measurement pieces arranged in the structural layer 22. The bioelectrical impedance measurement module 4 comprises at least two pairs of electrodes arranged on the inner side wall of the measurement cavity 21. The dimension measurement pieces and the electrodes are both arranged in an axial direction of the limb and are both electrically connected to the main control console 1. The dimension measurement module 3 is used for non-invasively obtaining the circumference information of the measured limb, and the bioelectrical impedance measurement module 4 is used for applying an excitation signal to the measured limb and detecting an impedance response. Thus, in this embodiment, the dimension measurement module 3 and the bioelectrical impedance measurement module 4 are integrated in the same measurement arm sleeve, and data synchronous acquisition and fusion processing are realized through the main control unit, so that the morphological parameters and the tissue composition parameters of the limb can be obtained simultaneously in a single measurement, thereby realizing rapid, objective and repeatable evaluation of lymphedema.

[0029] In this embodiment, the integrated measurement arm sleeve 2 is made of flexible medical material as a whole, and a hollow structural layer 22 is arranged between the inner layer and the outer layer for placing the dimension measurement pieces.

[0030] In the embodiment, the dimension measuring member is a pressure sensing ring belt, which comprises a micro pressure sensor array, and a micro air pump is arranged in the main control console 1, and the micro air pump is communicated with the measuring cavity 21 through a pipeline, and is used for inflating the measuring cavity 21 to make the arm sleeve fit the limb, and the pressure sensing ring belt reads the pressure distribution of each point, and is converted into an accurate circumference value through a pre-calibration algorithm. In the embodiment, the pressure sensing ring belt is arranged on a preset axial standardized site determined based on the limb bony landmarks; the standardized site includes: a site 10 cm away from the proximal end of the radial styloid, a site 5 cm away from the distal end of the olecranon of the ulna, and a site 10 cm away from the proximal end of the olecranon of the ulna, that is, there are three pressure sensing ring belts in total.

[0031] In the embodiment, the bioelectrical impedance measurement module 4 comprises two pairs of electrodes, that is, a four-electrode method is adopted, and the electrode pairs are arranged along the long axis of the limb, and the distal pair of electrodes is located at the wrist / hand, and the proximal pair of electrodes is located at the proximal end of the shoulder / upper arm. By transmitting a safe micro-current of a specific frequency, the electrical impedance spectrum data of the limb is measured, which is specially used for analyzing the content and characteristics of extracellular fluid.

[0032] In the embodiment, the integrated measuring arm sleeve 2 is connected with the main control console 1 through a cable, and a data processing module and a touch display screen are arranged in the main control console 1, and the data processing module comprises a processor, a BIA analysis circuit and a power module.

[0033] In the embodiment, the dimension measuring module 3 obtains the circumference information through the following steps: A1, constant low-pressure gas is filled into the structural layer 22, so that the structural layer 22 uniformly adheres to the surface of the measured limb.

[0034] Among them, the constant low-pressure gas is 10-30 mmHg.

[0035] A2, the circumferential pressure distribution P(θ) is collected through the pressure sensor array of all the pressure sensing ring belts.

[0036] Among them, θ is the circumferential angle, and the value range is 0-360°.

[0037] A3, based on the pre-calibrated pressure-deformation model, the approximate geometric profile of each section is reconstructed, and the pressure-deformation model is expressed as: R(θ)=R0+α (P(θ)-P avg ) / P avg ; In the formula, R(θ) is the radial distance at angle θ, R0 is the initial fitting radius, α is the material deformation coefficient, P(θ) is the pressure value at angle θ, and P avg is the average pressure of the section.

[0038] Wherein, the radial distance is the center of the integrated measuring arm sleeve 2 to the surface of the limb, the initial fitting radius is estimated by the inflation volume, and the material deformation coefficient is obtained by pre-calibration.

[0039] A4, based on the reconstructed contour point set {R(θ i )}, the perimeter of the polygon is calculated to obtain the circumference information C i of each standard site i The calculation process of the circumference information C A is as follows: ; In the formula, N is the number of pressure sensors.

[0040] Wherein, the circumference values of the three standardized sites obtained are C B , C C , and C B .

[0041] In the embodiment, the data processing module in the embodiment is used to: B1, based on the circumference information, the volume parameter of the limb is calculated.

[0042] Specifically, it includes: Combined with the distance between the standardized sites, the total volume V of the limb is calculated by using the piecewise trapezoidal integral method. Specifically, the calculation formula of the piecewise trapezoidal integral method is: V≈(L A -L B )×(C A ²+C B ²) / (8π)+(L C -L B )×(C B ²+C C ²) / (8π); In the formula, C A , C B , and C C are the circumference values of the three standardized sites, and L A , L B , and L C are the distances of the three standardized sites from the radial styloid process.

[0043] According to the above description, a complete and automatic quantitative process from circumference measurement of multiple standardized sites to total volume calculation of the limb is realized. The consistency and repeatability of the volume calculation result are ensured, and high-precision and high-efficiency morphological quantitative basis is provided for subsequent volume change rate calculation and long-term efficacy dynamic monitoring.

[0044] B2, based on the impedance response, the characteristic parameters of the limb are calculated.

[0045] In the embodiment, the limb feature parameter is extracellular fluid resistance ratio R ratio and phase angle PA, specifically comprising: B21, calculating complex impedance Z raw (f) at each frequency: Z raw (f)=R raw (f)+jX raw (f); wherein R raw (f) is the resistance component, X raw (f) is the reactance component, and j is the imaginary unit.

[0046] In the embodiment, a set of safe alternating excitation currents I(f) containing a specific low frequency is applied to the limb, and the corresponding voltage response U(f) is detected synchronously, the frequency can be 1 kHz, 5 kHz, 50 kHz, 100 kHz and 200 kHz, the specific low frequency is 5 kHz, and then the original complex impedance Z raw (f) is calculated by the above formula.

[0047] B22, extracting the resistance component at the frequency of 5 kHz, and calculating the extracellular fluid resistance ratio R ratio : R ratio =R ea / R eh ; wherein R ea is the baseline resistance value of the limb to be tested at 5 kHz, and R eh is the baseline resistance value of the healthy limb of the individual at 5 kHz.

[0048] wherein the resistance component at the frequency of 5 kHz mainly reflects the extracellular fluid capacity in the current path, and the current is difficult to penetrate the cell membrane due to its low frequency characteristics. At the same time, in order to eliminate individual differences and make longitudinal comparison, the above absolute parameters are converted into relative indexes. In clinical practice, lymphedema leads to abnormal increase of extracellular fluid in the affected side, and the conductivity is enhanced, so that R ea decreases, thereby causing R ratio <1. The degree of deviation from 1 can quantify the relative change of extracellular fluid.

[0049] B23, extracting the resistance component R raw (50kHz) and the reactance component X raw (f) at the frequency of 50 kHz, and calculating the phase angle PA: PA=arctan(X raw (50kHz) / R raw (50kHz)) (180 / π).

[0050] wherein the phase angle reflects the integrity of the cell membrane and the cell mass, and is a comprehensive index for evaluating the health status of the tissue. In this embodiment, by calculating the extracellular fluid resistance ratio and the 50 kHz phase angle, the bioelectrical impedance measurement module 4 can directly and quantitatively reflect the difference in tissue fluid volume between the affected side and the healthy side and the health status of the tissue, thereby improving the sensitivity of early-stage edema and helping to distinguish the high-protein fluid accumulation characteristic of lymphedema.

[0051] B3, fuse the volume parameter and the limb feature parameter to generate a comprehensive evaluation result of lymphedema.

[0052] In this embodiment, the main console 1 is used to display the circumference information, the volume parameter and the limb feature parameter, and the volume change rate and the index change rate compared with the healthy side data.

[0053] wherein after obtaining the volume parameter and the limb feature parameter, the evaluation is performed by generating multiple groups of parameters, mainly the volume change rate, and the calculation formula is: ΔV% = (ΔV / V healthy ) 100%; ΔV = V affected -V healthy ; In the formula, V affected is the current volume of the affected limb, and V healthy is the baseline volume of the healthy limb.

[0054] wherein the circumference information, the volume parameter, the limb feature parameter, the volume change rate and the index change rate are displayed through the touch display screen, and specific numerical values or historical trend graphs changing over time can be displayed, etc.

[0055] In this embodiment, the comprehensive evaluation result is generated based on a preset edema judgment standard after the fusion judgment according to the circumference information, the volume parameter and the limb feature parameter. Specifically, the edema judgment standard of this embodiment is as shown in Table 1. In Table 1, specific scores are given to represent whether there is edema, and in actual clinical practice, the common interactive evaluation logic of the circumference information, the volume parameter and the limb feature parameter can be summarized as: 1. morphological measurement 0 points, R ratio ≥ 0.9 and ΔV% < 5%: no edema is confirmed, and routine follow-up is performed; 2. morphological measurement 1-2 points, R ratio = 0.8-0.9 and PA slightly abnormal: highly suspicious edema, shorten the follow-up period, and recommend once every 2 weeks; 3. morphological measurement ≥ 2 points, R ratio < 0.8 and PA obviously abnormal: confirmed dominant edema, immediately start intervention; 4. The core index in the limb characteristic parameter is extracellular fluid resistance ratio R ratio , and 50 kHz phase angle PA is used to assist in evaluating the health status of the tissue. Therefore, when the morphological measurement results and the bioimpedance analysis results conflict, the historical trend chart of the morphological measurement, R ratio , and AV% is used for joint judgment, and the clinical symptoms are reviewed in priority.

[0056] Table 1. Edema judgment standard

[0057] Example two Please refer to Figure 1 , a breast cancer postoperative lymphedema identification device is applied to clinical experimental data or a few suspicious symptoms to achieve accurate measurement. Specifically, the data processing module is further used for: C1, fitting the impedance data of multiple frequencies to the Cole-Cole model by the nonlinear least squares method, and the complex impedance Z(ω) of the Cole-Cole model is represented as: Z(ω)=R ∞ +(R0-R ∞ ) / [1+(jωτ) α ]; ω=2πf; In the formula, R0 is the zero-frequency resistance, R ∞ is the infinite-frequency resistance, j is the imaginary unit, ω is the angular frequency, f is the measurement frequency, τ is the relaxation time constant, and α is the distribution coefficient.

[0058] Among them, the main purpose of collecting 1kHz, 100kHz, 200kHz and other frequency data is not to directly use a single frequency value, but to obtain a complete impedance spectrum for Cole-Cole equivalent circuit model fitting. The implementation process is: fitting the (R, X) data points of the above multiple frequencies to the Cole-Cole model by the nonlinear least squares method. This process solves the theoretical parameters with clear physiological significance: R0: anchored by 1kHz and other low-frequency data, theoretically reflecting the resistance of the pure extracellular fluid path, which is a purer extracellular fluid volume index than single-point R e .

[0059] R ∞ : anchored by 100kHz, 200kHz and other high-frequency data, reflecting the total resistance of the parallel connection of intracellular fluid and extracellular fluid.

[0060] Extracellular water ratio ECF R ratio : This ratio does not depend on the control of the healthy side, and directly quantifies the relative proportion of extracellular fluid in the affected limb itself, which is more specific.

[0061] R0 and ECF R obtained by multi-frequency fitting ratio R than single-point measurement e Less affected by individual tissue structure differences, better stability and sensitivity in early detection of small liquid accumulation and long-term tracking of small changes.

[0062] Wherein, the fitting process of the embodiment is: 1. Fitting target Find a set of optimal parameters (R0, R ∞ , τ, α) such that the overall error between the theoretical model curve calculated by the set of parameters and the complex impedance data {Z m (f1), Z meas (f2),..., Z meas (f meas )} actually measured at frequency points {f1, f2,..., f m} is minimized.

[0063] 2. Data preprocessing and input Separate the originally measured complex impedance into two real component sequences of resistance R and reactance X to form the input data matrix of the fitting algorithm.

[0064] 3. Core fitting calculation process The data processing module uses iterative optimization algorithms such as Levenberg-Marquardt algorithm for fitting, with the following steps: 3.1 Parameter initialization Assign reasonable initial estimated values to the four parameters to be solved (R0, R ∞ , τ, α).

[0065] 3.2 Theoretical value calculation Using the current parameter values, calculate the theoretical impedance Z i (f meas ) at all measurement frequencies f i using the Cole-Cole equation, and also separate it into theoretical resistance R meas (f i ) and theoretical reactance X meas (f i ).

[0066] 3.3 Error calculation f Calculate the residual sum of squares S between the measured value and the theoretical value as the objective function: .

[0067] 3.4 Iterative optimization The algorithm automatically adjusts the parameter values to minimize the objective function S. This process is repeated until a preset convergence condition is met, such as the change in S being less than a threshold value, or the maximum number of iterations is reached.

[0068] 3.5 Result output When the iteration converges, the final optimal parameter set (R0, R ∞ , τ, α) is output.

[0069] C2, based on the fitted parameters R0 and R ∞ , calculate the extracellular water ratio ECF R ratio : ECF R ratio = R0 / R ∞ .

[0070] Thus, by fitting the multi-frequency impedance data to the Cole-Cole model and solving the zero-frequency resistance R0 and the infinite-frequency resistance R ∞ , the extracellular water ratio unaffected by individual tissue structure differences can be calculated, thereby providing a more stable and specific relative proportion of extracellular fluid index, enhancing the analysis accuracy and interpretation power under complex tissue conditions and micro-time variation monitoring.

[0071] Example three Please refer to Figure 1 and Figure 2 , a method for identifying postoperative lymphedema of breast cancer, comprising the following steps: S1, the patient takes a sitting position, and the limb to be measured on the affected side is placed in the measurement cavity 21 of the integrated measurement arm sleeve 2.

[0072] S2, the dimension measurement module 3 non-invasively acquires the circumference information of the measured limb through multiple dimension measurement members.

[0073] S3, at least two pairs of electrodes on the bioelectrical impedance measurement module 4 apply an excitation signal to the measured limb and detect the impedance response.

[0074] S4, based on the circumference information and the impedance response, a comprehensive evaluation result of lymphedema is generated.

[0075] Among them, for the specific implementation and specific effect of each step, refer to the description of the corresponding module of example one.

[0076] In summary, the overall technical scheme of the present application realizes the systematic improvement of the existing clinical evaluation method, and achieves significant technical progress and clinical practical value, realizing the rapid, objective and repeatable evaluation of lymphedema, which specifically includes: 1. Comprehensive and objective evaluation The first to integrate standardized automatic dimension measurement and targeted BIA component analysis in a single device. One measurement can obtain both morphological size and intrinsic property quantitative data, providing more comprehensive decision-making basis for clinical practice.

[0077] 2. Standardization and high repeatability Mechanically automatic positioning of standard anatomical planes for measurement completely eliminates subjective errors caused by positioning and manual methods in manual measurement, ensuring high repeatability and longitudinal comparability of measurement results.

[0078] 3. Overcome the limitations of traditional measurement BIA is more sensitive to changes in tissue extracellular fluid than circumference measurement, which helps to detect lymphatic return obstruction earlier. At the same time, the selection of limb characteristic parameters helps to distinguish lymphedema from swelling caused by other reasons, improving the specificity of differentiation.

[0079] 4. Improve clinical efficiency and experience The operation process is simple and fast, similar to measuring blood pressure, and a single measurement can be completed in a few minutes, suitable for outpatient and bedside use. Integrated design reduces the number of devices and operation complexity, improving the experience of patients and medical staff.

[0080] 5. Support dynamic and accurate monitoring Automatic data storage and fusion analysis function makes long-term and multi-time point efficacy tracking simple and accurate, and can intuitively show the progress or regression trend of edema.

[0081] Since the system / device described in the above embodiments of the present application is used to implement the method of the above embodiments of the present application, the specific structure and modification of the system / device can be understood by those skilled in the art based on the method described in the above embodiments of the present application, and thus will not be described here. Any system / device used in the method of the above embodiments of the present application belongs to the scope of the present application.

[0082] Those skilled in the art should understand that the embodiments of the present application can be provided as a method, device or computer program product. Therefore, the present application can be in the form of a complete hardware embodiment, a complete software embodiment, or an embodiment combining software and hardware aspects. Moreover, the present application can be in the form of a computer program product implemented on one or more computer usable storage media (including but not limited to magnetic disk storage, CD-ROM, optical storage, etc.) containing computer usable program code.

[0083] This invention is described with reference to flowchart illustrations and / or block diagrams of methods, apparatus (devices), and computer program products according to embodiments of the invention. It will be understood that each block of the flowchart illustrations and / or block diagrams, as well as combinations of blocks in the flowchart illustrations and / or block diagrams, can be implemented by computer program instructions.

[0084] It should be noted that any reference numerals placed between parentheses in the claims should not be construed as limiting the claims. The word "comprising" does not exclude the presence of components or steps not listed in the claims. The word "a" or "an" preceding a component does not exclude the presence of a plurality of such components. The invention can be implemented by means of hardware comprising several different components and by means of a suitably programmed computer. In claims that enumerate several means, several of these means may be embodied by the same hardware. The use of the terms first, second, third, etc., is merely for convenience of expression and does not indicate any order. These terms can be understood as part of the component names.

[0085] Furthermore, it should be noted that in the description of this specification, the terms "one embodiment," "some embodiments," "embodiment," "example," "specific example," or "some examples," etc., refer to specific features, structures, materials, or characteristics described in connection with that embodiment or example, which are included in at least one embodiment or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. Furthermore, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.

[0086] Although preferred embodiments of the invention have been described, those skilled in the art, upon learning the basic inventive concept, can make other changes and modifications to these embodiments. Therefore, the claims should be interpreted to include both the preferred embodiments and all changes and modifications falling within the scope of the invention.

[0087] Obviously, those skilled in the art can make various modifications and variations to this invention without departing from its spirit and scope. Therefore, if these modifications and variations fall within the scope of the claims of this invention and their equivalents, then this invention should also include these modifications and variations.

Claims

1. An apparatus for identifying a breast cancer postoperative lymphedema condition, characterized by, The main console, an integrated measuring arm sleeve, a dimension measurement module and a bioelectrical impedance measurement module are included. The integrated measuring arm sleeve includes a measuring cavity for accommodating a measured limb and a structural layer outside the measuring cavity, the dimension measurement module includes a plurality of dimension measurement pieces arranged in the structural layer, and the bioelectrical impedance measurement module includes at least two pairs of electrodes arranged on the inner side wall of the measuring cavity, the dimension measurement pieces and the electrodes are arranged at intervals along the limb axis, and are electrically connected to the main console. The dimension measurement module is used for non-invasively obtaining the circumference information of the measured limb, and the bioelectrical impedance measurement module is used for applying an excitation signal to the measured limb and detecting an impedance response.

2. The apparatus for identifying lymphedema after breast cancer surgery according to claim 1, wherein The data processing module in the main console is used for: calculating a volume parameter of the limb based on the circumference information; calculating a limb characteristic parameter based on the impedance response; fusing the volume parameter and the limb characteristic parameter to generate a comprehensive evaluation result of lymphedema.

3. The apparatus for identifying the status of lymphedema after breast cancer surgery according to claim 2, wherein The dimension measurement piece is a pressure sensing ring belt including a micro pressure sensor array, and a micro air pump is arranged in the main console, which is communicated with the measuring cavity through a pipeline and is used for inflating the measuring cavity to make the arm sleeve fit the limb.

4. The apparatus for identifying the status of lymphedema after breast cancer surgery according to claim 3, wherein The pressure sensing ring belt is arranged on a preset axial standardized site determined based on limb bony landmarks; the standardized site includes: 10 cm proximal to the radial styloid, 5 cm distal to the ulnar olecranon, and 10 cm proximal to the ulnar olecranon.

5. The apparatus for identifying the status of lymphedema after breast cancer surgery according to claim 4, wherein The dimension measurement module obtaining the circumference information includes the following steps: filling the structural layer with constant low-pressure gas to make the structural layer uniformly fit the surface of the measured limb; collecting the circumferential pressure distribution P(θ) through the pressure sensor array of all pressure sensing ring belts; reconstructing the approximate geometric profile of each section based on a pre-marked pressure-deformation model, which is expressed as: R(θ) = R0+ a (P(θ) - P avg ) / P avg ; where R(0) is the radial distance at angle 0, R0is the initial fit radius, a is the material deformation coefficient, P(0) is the pressure value at angle 0, P avg is the cross-sectional average pressure; Based on the reconstructed contour point set {R(θ i )}, the perimeter of the polygon is calculated to obtain the circumference information C i of each standard site i . The calculation process is as follows: ； wherein N is the number of pressure sensors; When the data processing module is used for calculating the volume parameter of the limb based on the circumference information, it includes: combining the spacing of each standardized site, and using the piecewise trapezoidal integration method to calculate the total volume V of the limb.

6. The apparatus for identifying the status of lymphedema after breast cancer surgery according to claim 5, wherein The calculation formula of the piecewise trapezoidal integration method is: V≈(L B -L A )×(C A ²+C B ²) / (8π)+(L C -L B )×(C B ²+C C ²) / (8π); where C A , C B , and C C are the circumferential values of the three standardized sites, L A , L B , and L C are the distances of the three standardized sites from the radial styloid.

7. The apparatus for identifying the status of lymphedema after breast cancer surgery according to claim 2, wherein The limb characteristic parameter is extracellular fluid resistance ratio R ratio And phase angle PA, the data processing module is used for calculating the limb characteristic parameter based on the impedance response, comprising: The complex impedance Z at each frequency is calculated raw (f): Z raw (f)=R raw (f)+jX raw (f); wherein R raw (f) is a resistance component, X raw (f) is a reactance component, j is the imaginary unit; The resistance component at 5 kHz frequency was extracted, and the extracellular fluid resistance ratio R was calculated ratio : R ratio = R ea / R eh ; wherein R ea is the baseline resistance value of the limb being tested at 5 kHz, R eh is the baseline resistance value of the individual's healthy limb at 5 kHz; extracting the resistance component R at a frequency of 50 kHz raw (50 kHz) and the reactance component X raw (f), calculating the phase angle PA: PA = arctan(X raw (50 kHz) / R raw (50 kHz) (180 / π).

8. The apparatus for identifying the status of lymphedema after breast cancer surgery according to claim 7, wherein The data processing module is also used for: fitting the impedance data at multiple frequencies to a Cole-Cole model by a nonlinear least squares method, and the complex impedance Z(ω) of the Cole-Cole model is expressed as: Z(ω) = R ∞ + (R0- R ∞ ) / [1+(jωτ) α ] ω=2πf; In the formula, R0 is the zero-frequency resistance, R ∞ For an infinite frequency resistor, j is the imaginary unit, ω is the angular frequency, f is the measurement frequency, τ is the relaxation time constant, and α is the distribution coefficient; Based on the fitted parameters R0 and R ∞ , the extracellular water fraction ECF R ratio is calculated: ECF R ratio = R0 / R ∞ .

9. An apparatus for identifying the status of lymphedema following surgery for breast cancer according to any one of claims 2 to 8, characterized in that, The main console is used for displaying the circumference information, the volume parameter and the limb characteristic parameter, and the volume change rate and the index change rate compared with the healthy side data; The comprehensive evaluation result is generated based on a preset edema judgment standard after fusing and judging the circumference information, the volume parameter and the limb characteristic parameter.

10. A method for identifying a breast cancer postoperative lymphedema condition, characterized by, The steps include: The patient takes a sitting position, and the measured limb of the affected side is placed in the measuring cavity of the integrated measuring arm sleeve; The dimension measurement module non-invasively obtains the circumference information of the measured limb through a plurality of dimension measurement pieces; The bioelectrical impedance measurement module applies an excitation signal to the measured limb through at least two pairs of electrodes and detects an impedance response; Based on the circumference information and the impedance response, a comprehensive assessment result of lymphedema is generated. Based on the circumference information and the impedance response, a comprehensive assessment result of lymphedema is generated.

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