Airway lesion measurement system and method based on composite driving and modeling

Abstract

The invention relates to an airway lesion measurement system and method based on composite driving and modeling, the system can enter an airway through a bronchoscope to measure the diameter and length of a lesion site, and the system comprises a composite driving expansion module which comprises a pneumatic bag cavity and a shape memory alloy skeleton and is used for executing an expansion step; the self-locking anchoring module is integrated on the shape memory alloy framework and is used for executing a self-locking step; the three-dimensional dynamic modeling module comprises a sensor array and a data processing unit which are arranged on the shape memory alloy framework and is used for executing a modeling step; and the respiration synchronization module is used for receiving a respiration gating signal of the bronchoscope and controlling the three-dimensional dynamic modeling module to carry out data acquisition in a preset time window of end expiration. Compared with the prior art, the method has the advantages of being efficient in operation, convenient, easy to use, accurate and reliable in measurement performance, good in safety performance and the like.

Description

Technical Field

[0001] This invention relates to the field of airway lesion measurement technology, and in particular to an airway lesion measurement system and method based on composite driving and modeling. Background Technology

[0002] Airway diseases, such as tumors and scar stenosis, are common respiratory system diseases. In clinical diagnosis and treatment, accurate measurement of the geometric parameters of the lesion site (such as the minimum diameter of the stenosis, lesion length, stenosis rate, and surface area) is of vital importance for developing surgical plans, selecting stent sizes, evaluating treatment effects, and predicting prognosis.

[0003] Currently, the three main methods commonly used in clinical practice for measuring airway lesions are as follows: Medical imaging measurements primarily rely on computed tomography (CT) scans and their three-dimensional reconstruction images. This method has significant drawbacks: First, CT images are static and cannot reflect the dynamic changes in the airway during respiratory movements, leading to discrepancies between measurement results and the actual intraoperative situation; second, its spatial resolution is limited, resulting in insufficient accuracy for measuring millimeter-level lesions or complex morphologies; finally, CT scans involve radiation doses, making real-time, repeatable measurement guidance during interventional procedures impossible.

[0004] Bronchoscopy-based visual estimation: Doctors directly observe lesions through the camera of a bronchoscope and make visual estimations based on experience. This method is highly subjective, heavily reliant on the operator's personal experience, and the assessment results vary greatly between different doctors. It lacks objective and quantifiable standards, making it difficult to meet the needs of precision medicine.

[0005] Traditional mechanical measuring tools, such as balloon catheters or rigid probes, are used for exploratory measurements. These tools can compress tissue when passing through narrow areas, leading to measurement distortion. More importantly, they are typically rigid or semi-rigid structures, which can easily cause mucosal damage, bleeding, or even perforation in complex and irregular airways, posing a high safety risk. Furthermore, they generally only provide coarse information in a single dimension, such as diameter or permeability, and cannot simultaneously acquire comprehensive three-dimensional geometric parameters such as length and surface area.

[0006] In summary, existing technologies share the following common drawbacks: Insufficient accuracy: Limited by the resolution of static images or human estimation, it is difficult to achieve millimeter-level accurate measurements.

[0007] Non-real-time nature: It cannot provide dynamic, real-time quantitative data during the operation, thus its guiding value is limited.

[0008] Poor safety: Mechanical contact measurement can easily cause tissue damage, and the risk is difficult to control.

[0009] Limited information dimensions: It is difficult to conduct a comprehensive three-dimensional quantitative assessment of lesions, such as simultaneously obtaining diameter, length, stenosis rate, and surface area.

[0010] Therefore, there is an urgent need in this field for a new airway lesion measurement technology that can be seamlessly integrated with the bronchoscopic surgical procedure, and that is minimally invasive, real-time, accurate, safe, and can provide multi-dimensional quantitative information. Summary of the Invention

[0011] The purpose of this invention is to overcome the shortcomings of the existing technology and provide an airway lesion measurement system and method based on composite driving and modeling, which is efficient, convenient and easy to use, with accurate and reliable measurement performance and good safety performance.

[0012] The objective of this invention can be achieved through the following technical solutions: This invention provides an airway lesion measurement system based on composite driving and modeling, which can enter the airway via a bronchoscope to measure the diameter and length of lesion sites, including: The composite-driven deployment module includes a pneumatic cavity and a shape memory alloy skeleton for performing the deployment steps; A self-locking anchoring module is integrated on the shape memory alloy skeleton to perform the self-locking step; The three-dimensional dynamic modeling module includes a sensor array and a data processing unit disposed on the shape memory alloy skeleton, for performing modeling steps; The respiratory synchronization module is used to receive the respiratory gating signal from the bronchoscope and control the three-dimensional dynamic modeling module to collect data within a preset time window at the end of expiration. Furthermore, the composite drive deployment module also includes: A miniature air pump is connected to the pneumatic bladder cavity via a nanoscale air passageway. Piezoelectric ceramic valves are installed in the pneumatic system to monitor and regulate inflation pressure in real time.

[0013] Furthermore, the shape memory alloy skeleton is a honeycomb mesh structure woven from ultra-elastic nickel-titanium alloy wires. The phase transformation temperature is 35°C, and the mesh porosity is 62%. Furthermore, the self-locking anchoring module includes: a skeleton with 6 main ribs and 6 secondary ribs arranged radially at an angle of 22.5°, wherein the ends of the main ribs are laser-engraved with titanium alloy barbs; the surface of the skeleton is covered with a microporous hydrophilic coating, which is used to adsorb liquid on the surface of the mucous membrane to generate negative pressure adsorption force when unfolded.

[0014] Furthermore, the sensor array includes: Multiple piezoresistive sensors are used to collect circumferential pressure distribution data. Multiple fiber Bragg grating sensors record the longitudinal strain distribution at millisecond intervals.

[0015] Furthermore, it also includes a security monitoring module, which is configured as follows: When the pressure inside the pneumatic bladder exceeds 15 kPa, automatic pressure relief is initiated. When the embedding force of the self-locking anchoring module exceeds 0.15N, an audible and visual alarm is triggered and the measuring device is controlled to retract.

[0016] This invention also provides a measurement method for an airway lesion measurement system based on composite driving and modeling, comprising the following steps: S1: Deployment steps: The measuring device is deployed at the airway lesion site through a composite drive deployment mechanism. The composite drive deployment mechanism includes: rapid pre-deployment of the skeleton by inflating the pneumatic bladder with gas, and simultaneous deployment of the skeleton into the final lantern shape by using shape memory alloy under body temperature trigger phase change. S2: Self-locking step: Through the self-locking asymmetric structure of the skeleton, the barbs on the skeleton pierce into the mucosal epithelium and, in conjunction with negative pressure adsorption, stably anchor the measuring device to the lesion site. S3: Modeling steps: Collect circumferential pressure distribution data and longitudinal strain data of the lesion site by setting up a sensor array on the skeleton, construct a three-dimensional model of the lesion site based on a multi-source data fusion algorithm, and output the geometric parameters of the lesion. In the S3 modeling step, real-time respiratory gating signals from the bronchoscope are integrated, and data is collected within a preset time window at the end of expiration to eliminate respiratory motion artifacts.

[0017] Furthermore, the inflation pressure of the pneumatic bladder is controlled within the range of 10kPa±0.5kPa, and the skeleton pre-expansion is completed within 0.3 seconds; the shape memory alloy skeleton triggers a phase transition when in contact with a body temperature ≥35℃, and fully expands within 0.7 seconds. Furthermore, in S2, the self-locking asymmetric structure includes multiple main ribs and secondary ribs arranged radially at an angle, with barbs at the ends of the main ribs; when the contact pressure between the barbs and the mucosa is greater than 0.05N, the barbs automatically penetrate the mucosal epithelium, with an penetration depth ≤40μm. Furthermore, the S3 modeling steps specifically include: Based on the circumferential pressure distribution data, the local radius of curvature is calculated in real time using the Hertzian contact model. Based on the longitudinal strain data, a longitudinal profile curve is fitted. The local radius of curvature and the longitudinal contour curve are fused to generate three-dimensional point cloud data of the lesion site; The 3D point cloud data is reconstructed using NURBS surface modeling to obtain the 3D model, and the minimum diameter D is calculated and output. min Maximum diameter D max At least one of the following geometric parameters: lesion length L, stenosis rate η.

[0018] Compared with the prior art, the present invention has the following advantages: (1) Highly efficient, convenient, and easy to use. The operation process is highly simplified, adopting a "one-click expansion / contraction" design, which reduces the difficulty of operation and the technical threshold. There is no need for complicated instrument preparation or cumbersome steps. Measurement can be completed simply by inserting the instrument through the working channel of the bronchoscope, which shortens the operation time and improves the efficiency of diagnosis and treatment. The system can collect data in real time (millisecond response) during the operation and generate three-dimensional models and measurement results, providing doctors with immediate decision support.

[0019] (2) Precise and reliable measurement performance. Combining a highly sensitive piezoresistive sensor and a high-resolution fiber optic grating sensor, it directly measures tissue contact, avoiding problems such as magnification and distortion of medical images. The measurement accuracy is far higher than that of CT visual estimation. It breaks through the limitation of traditional methods that can only measure diameter or length, and can simultaneously output multiple key three-dimensional geometric parameters such as minimum diameter (D_min), maximum diameter (D_max), lesion length (L), stenosis rate (η), and surface area (S). It is beneficial for assessing the extent of tumor invasion and formulating precise treatment plans. By freezing data acquisition within the window at the moment of "end-expiration", artifacts caused by the patient's respiratory movements are effectively eliminated, ensuring the stability and repeatability of measurement results and solving the measurement problem in dynamic environments.

[0020] (3) Excellent safety performance. Truly minimally invasive and tissue-friendly: The device enters through the natural cavity of the bronchoscope without the need for additional incisions. Its flexible material and controllable deployment force, combined with multiple safety monitoring mechanisms, minimize the risks of mucosal damage, bleeding, or perforation caused by mechanical expansion. The insertion depth of the self-locking barb is precisely limited to the upper mucosal layer of ≤40μm, and it is equipped with trigger and release thresholds, which not only ensures the stability during measurement but also ensures the controllability and reversibility of the anchoring process, resulting in high biosafety. Attached Figure Description

[0021] Figure 1 This is a schematic diagram of an airway lesion measurement system based on composite drive and modeling.

[0022] Figure labels: 1-bronchoscope; 2-composite drive deployment module; 3-breathing synchronization module. Detailed Implementation

[0023] The present invention will now be described in detail with reference to the accompanying drawings and specific embodiments. Component models, material names, connection structures, control methods, algorithms, and other features not explicitly described in this technical solution are considered common technical features disclosed in the prior art.

[0024] Example 1 This embodiment provides an airway lesion measurement system based on composite driving and modeling, which can enter the airway through a bronchoscope 1 to measure the diameter and length of the lesion site, such as... Figure 1 As shown, it includes: The composite-driven deployment module 2 includes a pneumatic bladder and a shape memory alloy skeleton for performing the deployment steps; A self-locking anchoring module is integrated on the shape memory alloy skeleton to perform the self-locking step; The three-dimensional dynamic modeling module includes a sensor array and a data processing unit disposed on the shape memory alloy skeleton, for performing modeling steps; The respiratory synchronization module 3 is used to receive the respiratory gating signal from the bronchoscope and control the three-dimensional dynamic modeling module to collect data within a preset time window at the end of expiration. In a specific implementation, the composite drive deployment module 2 further includes: A miniature air pump is connected to the pneumatic bladder cavity via a nanoscale air passageway. Piezoelectric ceramic valves are installed in the pneumatic system to monitor and regulate inflation pressure in real time.

[0025] In a specific embodiment, the shape memory alloy skeleton is a honeycomb mesh structure woven from ultra-elastic nickel-titanium alloy wires. The phase transformation temperature is 35°C, and the mesh porosity is 62%. In a specific embodiment, the self-locking anchoring module includes: a skeleton with 6 main ribs and 6 secondary ribs arranged radially at an angle of 22.5°, wherein the ends of the main ribs are laser-engraved with titanium alloy barbs; the surface of the skeleton is covered with a microporous hydrophilic coating, which is used to adsorb liquid on the surface of the mucous membrane to generate negative pressure adsorption force when unfolded.

[0026] In a specific embodiment, the sensor array includes: Multiple piezoresistive sensors are used to collect circumferential pressure distribution data. Multiple fiber Bragg grating sensors record the longitudinal strain distribution at millisecond intervals.

[0027] In a specific implementation, a security monitoring module is also included, which is configured as follows: When the pressure inside the pneumatic bladder exceeds 15 kPa, automatic pressure relief is initiated. When the embedding force of the self-locking anchoring module exceeds 0.15N, an audible and visual alarm is triggered and the measuring device is controlled to retract.

[0028] Example 2 This embodiment provides a measurement method for an airway lesion measurement system based on composite driving and modeling, including the following steps: S1: Deployment steps: The measuring device is deployed at the airway lesion site through a composite drive deployment mechanism. The composite drive deployment mechanism includes: rapid pre-deployment of the skeleton by inflating the pneumatic bladder with gas, and simultaneous deployment of the skeleton into the final lantern shape by using shape memory alloy under body temperature trigger phase change. S2: Self-locking step: Through the self-locking asymmetric structure of the skeleton, the barbs on the skeleton pierce into the mucosal epithelium and, in conjunction with negative pressure adsorption, stably anchor the measuring device to the lesion site. S3: Modeling steps: Collect circumferential pressure distribution data and longitudinal strain data of the lesion site by setting up a sensor array on the skeleton, construct a three-dimensional model of the lesion site based on a multi-source data fusion algorithm, and output the geometric parameters of the lesion. In the S3 modeling step, the real-time respiratory gating signal from bronchoscope 1 is integrated, and data is collected within a preset time window at the end of expiration to eliminate respiratory motion artifacts.

[0029] In a specific embodiment, the inflation pressure of the pneumatic bladder is controlled within the range of 10kPa±0.5kPa, and the skeleton pre-expansion is completed within 0.3 seconds; the shape memory alloy skeleton triggers a phase transition when in contact with a body temperature ≥35℃, and fully expands within 0.7 seconds. In a specific implementation, in S2, the self-locking asymmetric structure includes multiple main ribs and secondary ribs arranged radially at an angle, with barbs at the ends of the main ribs; when the contact pressure between the barbs and the mucosa is greater than 0.05N, the barbs automatically penetrate the mucosal epithelium, with an penetration depth ≤40μm. In a specific implementation, the S3 modeling step specifically includes: Based on the circumferential pressure distribution data, the local radius of curvature is calculated in real time using the Hertzian contact model. Based on the longitudinal strain data, a longitudinal profile curve is fitted. The local radius of curvature and the longitudinal contour curve are fused to generate three-dimensional point cloud data of the lesion site; The 3D point cloud data is reconstructed using NURBS surface modeling to obtain the 3D model, and the minimum diameter D is calculated and output. min Maximum diameter D max At least one of the following geometric parameters: lesion length L, stenosis rate η.

[0030] Components not described in detail in this embodiment are all existing components that can be purchased through public channels.

[0031] The above description of the embodiments is provided to enable those skilled in the art to understand and use the invention. It will be apparent to those skilled in the art that various modifications can be made to these embodiments, and the general principles described herein can be applied to other embodiments without inventive effort. Therefore, the present invention is not limited to the above embodiments, and any improvements and modifications made by those skilled in the art based on the disclosure of the present invention without departing from the scope of the invention should be within the protection scope of the present invention.

Claims

1. A system for measuring airway lesions based on composite driving and modeling, characterized in that, It allows access to the airway via a bronchoscope (1) to measure the diameter and length of the lesion site, including: The composite drive deployment module (2) includes a pneumatic bladder and a shape memory alloy skeleton for performing the deployment steps; A self-locking anchoring module is integrated on the shape memory alloy skeleton to perform the self-locking step; The three-dimensional dynamic modeling module includes a sensor array and a data processing unit disposed on the shape memory alloy skeleton, for performing modeling steps; The respiratory synchronization module (3) is used to receive the respiratory gating signal from the bronchoscope and control the three-dimensional dynamic modeling module to collect data within a preset time window at the end of expiration.

2. The airway lesion measurement system based on composite driving and modeling according to claim 1, characterized in that, The composite drive deployment module (2) also includes: A miniature air pump is connected to the pneumatic bladder cavity via a nanoscale air passageway. Piezoelectric ceramic valves are installed in the pneumatic system to monitor and regulate inflation pressure in real time.

3. The airway lesion measurement system based on composite driving and modeling according to claim 1, characterized in that, The shape memory alloy skeleton is a honeycomb mesh structure woven from superelastic nickel-titanium alloy wires.

4. The airway lesion measurement system based on composite driving and modeling according to claim 1, characterized in that, The self-locking anchoring module includes: a skeleton with 6 main ribs and 6 secondary ribs arranged radially at a 22.5° angle, the ends of the main ribs being laser-engraved with titanium alloy barbs; the surface of the skeleton is covered with a microporous hydrophilic coating, which is used to adsorb liquid on the mucous membrane surface to generate negative pressure adsorption force when unfolded.

5. The airway lesion measurement system based on composite driving and modeling according to claim 1, characterized in that, The sensor array includes: Multiple piezoresistive sensors collect circumferential pressure distribution data; Multiple fiber Bragg grating sensors record the longitudinal strain distribution at millisecond intervals.

6. The airway lesion measurement system based on composite driving and modeling according to claim 1, characterized in that, It also includes a security monitoring module, which is configured as follows: When the pressure inside the pneumatic bladder exceeds 15 kPa, automatic pressure relief is initiated. When the embedding force of the self-locking anchoring module exceeds 0.15N, an audible and visual alarm is triggered and the measuring device is controlled to retract.

7. A measurement method for an airway lesion measurement system based on composite driving and modeling as described in any one of claims 1-6, characterized in that, Includes the following steps: S1: Deployment steps: The measuring device is deployed at the airway lesion site through a composite drive deployment mechanism. The composite drive deployment mechanism includes: rapid pre-deployment of the skeleton by inflating the pneumatic bladder with gas, and simultaneous deployment of the skeleton into the final lantern shape by using shape memory alloy under body temperature trigger phase change. S2: Self-locking step: Through the self-locking asymmetric structure of the skeleton, the barbs on the skeleton pierce into the mucosal epithelium and, in conjunction with negative pressure adsorption, stably anchor the measuring device to the lesion site. S3: Modeling steps: Collect circumferential pressure distribution data and longitudinal strain data of the lesion site by setting up a sensor array on the skeleton, construct a three-dimensional model of the lesion site based on a multi-source data fusion algorithm, and output the geometric parameters of the lesion. In the S3 modeling step, the real-time respiratory gating signal of the bronchoscope (1) is integrated, and data is collected within a preset time window at the end of expiration to eliminate respiratory motion artifacts.

8. The measurement method of the airway lesion measurement system based on composite driving and modeling according to claim 7, characterized in that, The inflation pressure of the pneumatic bladder is controlled within the range of 10kPa±0.5kPa, and the skeleton pre-expansion is completed within 0.3 seconds; the shape memory alloy skeleton triggers a phase transition when in contact with a body temperature ≥35℃, and fully expands within 0.7 seconds.

9. The measurement method of the airway lesion measurement system based on composite driving and modeling according to claim 7, characterized in that, In S2, the self-locking asymmetric structure includes multiple main ribs and secondary ribs arranged radially at an angle, with barbs at the ends of the main ribs; when the contact pressure between the barbs and the mucosa is greater than 0.05N, the barbs automatically penetrate the mucosal epithelium with a penetration depth ≤40μm.

10. The measurement method of the airway lesion measurement system based on composite driving and modeling according to claim 7, characterized in that, The S3 modeling steps specifically include: Based on the circumferential pressure distribution data, the local radius of curvature is calculated in real time using the Hertzian contact model. Based on the longitudinal strain data, a longitudinal profile curve is fitted. The local radius of curvature and the longitudinal contour curve are fused to generate three-dimensional point cloud data of the lesion site; The three-dimensional point cloud data is reconstructed using NURBS surface modeling to obtain the three-dimensional model, and at least one of the following geometric parameters is calculated and output: minimum diameter Dmin, maximum diameter Dmax, lesion length L, and stenosis rate η.

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