A system and device for locating intraductal lesions of the breast based on PROLENE sutures

Abstract

This specification provides a system and device for locating intraductal lesions of the breast based on PROLENE sutures, relating to the field of intelligent medicine. It includes: a ductoscope insertion module configured to insert a ductoscope with a cannula into the breast duct and reach the lesion area; a suture insertion module configured to pass one end of the suture through a side hole in the cannula to reach the lesion area; a suture insertion distance marking module configured to identify a first position of the exposed suture segment outside the cannula and measure the distance from the distance mark to the nipple; a ductoscope withdrawal module configured to withdraw the ductoscope while observing the ductoscope's field of view, positioning the suture around the lesion area; and a distance correction module configured to, after withdrawing the ductoscope, identify the current position of the distance mark on the suture, determine whether the current position matches the first position, and if not, adjust the distance mark to the first position. Using sutures does not damage the tumor or surrounding tissue, reduces the risk of missed diagnoses, and causes no discomfort during the procedure.

Description

Technical Field

[0001] This invention relates to the field of intelligent medical care, and more specifically, to a system and apparatus for locating intraductal lesions of the breast based on PROLENE sutures. Background Technology

[0002] Pathological nipple discharge (PND) is common in clinical practice and is the third most common breast condition after pain and lumps. It is usually benign, but the risk of malignancy is higher when the discharge is from a single duct, unilateral, spontaneous, persistent, bloody or serous, and when accompanied by a breast lump. In the early stages of the disease, the lesion within the mammary duct is very small, only a few millimeters in diameter, usually less than 3 millimeters.

[0003] Currently, fibrocystic breast surgery (FDS) is the globally recognized standard method for diagnosing papillomatosis, possessing relatively high sensitivity and specificity. FDS can clearly visualize lesions, avoiding unnecessary surgery. However, due to the very small size of the lesions, they are easily missed during pathological examination; therefore, lesion localization is crucial. Unhooked wires facilitate the removal of intraductal tumors for pathological diagnosis. However, unhooked wires are expensive and not commonly used, and they can damage the lesion area and surrounding tissue. If the lesion is malignant, bleeding and injury can easily occur during localization, potentially leading to tumor metastasis. Summary of the Invention

[0004] This invention aims to at least solve one of the technical problems existing in the prior art. To this end, this invention provides a system and device for locating intraductal lesions of the breast based on PROLENE sutures; by innovatively using PROLENE sutures commonly used in surgery for lesion location, PROLENE sutures possess a certain degree of rigidity and flexibility, and are low in cost and widely applicable.

[0005] The first aspect of this application discloses a system for locating intraductal lesions of the breast based on PROLENE sutures, comprising: The ductoscope insertion module is configured to insert a ductoscope into the mammary duct and reach the lesion area, with a cannula attached to the mammary duct. The suture insertion module is configured to pass one end of the suture through the side hole of the cannula, so that one end of the suture reaches the lesion area. The suture insertion distance marker module is configured to identify the first position of the exposed suture section outside the cannula, output a prompt message indicating that a distance marker is set at the first position, and measure the distance from the distance marker to the nipple; The ductoscope withdrawal module is configured to withdraw the ductoscope and cannula while observing the ductoscope's field of view, so that the suture is positioned around the lesion area and does not come out with the cannula. The distance correction module is configured to, after the ductoscope and cannula are removed, identify the current position of the distance mark on the suture, determine whether the current position is consistent with a first position, and if not, adjust the distance mark to the first position.

[0006] A second aspect of this application discloses a device for locating intraductal lesions of the breast based on PROLENE sutures. The device includes: one or more processors and a memory; the memory is used to store one or more computer programs; when the one or more computer programs are executed by the one or more processors, the following steps are performed: S101, inserting a ductoscope into the mammary duct and reaching the lesion area, with a cannula attached to the mammary duct; S102, pass one end of the suture through the side hole of the cannula so that one end of the suture reaches the lesion area; S103, identify the first position of the exposed suture section outside the cannula, output a prompt message indicating that a distance mark is set at the first position, and measure the distance from the distance mark to the nipple; S104, while observing the field of view of the ductoscope, withdraw the ductoscope and cannula so that the suture is positioned around the lesion area; S105, after removing the ductoscope and cannula, identify the current position of the distance mark on the suture, and determine whether the current position is consistent with the first position. If they are inconsistent, adjust the distance mark to the first position.

[0007] Compared with existing technologies that involve inserting a hook through a side hole and fixing the hook to the tissue adjacent to the lesion, this application has the following advantages: 1. Using PROLENE sutures for guidance avoids damage and bleeding to the lesion and surrounding tissues, which is beneficial for postoperative pathological analysis; 2. To prevent the metastasis of malignant tumor cells that may occur after the lesion is damaged; 3. From the end of lesion marking to the preoperative period, PROLENE sutures provide patients with greater comfort; 4. Both methods have the same guiding effect on the lesion and can achieve the goal of accurately removing the lesion.

[0008] PROLENE sutures are safe and reliable for marking and guiding lesions, without damaging the tumor or surrounding tissue. Patients experience no discomfort during the procedure, and it is cost-effective. More importantly, it helps pathologists better detect lesions, even small ones that are easily missed, enabling clinicians to make more accurate prognostic assessments. Therefore, it is worthy of clinical promotion. Attached Figure Description

[0009] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0010] Figure 1 This is a schematic diagram of a system for locating intraductal lesions of the breast based on PROLENE sutures, provided in an embodiment of the present invention. Figure 2 This is a schematic diagram of the operation for locating intraductal lesions of the breast based on PROLENE sutures, provided in an embodiment of the present invention. Figure 3 This is a schematic diagram showing that, after the suture is positioned according to an embodiment of the present invention, one end of the suture is inside the milk duct and the other end is outside the nipple. Figure 4 This is a schematic diagram of the flat-head needle positioning of the overflow milk tube provided in an embodiment of the present invention; Figure 5 This is a schematic diagram of a tumor growing on the wall of a mammary duct as observed under a ductoscope according to an embodiment of the present invention; Figure 6 This is a schematic diagram of a tumor growing on the wall of a mammary duct and the observed mammary duct lumen as observed under a ductoscope according to an embodiment of the present invention. Figure 7 This is a schematic diagram of the pink duct wall, duct lumen, and duct bifurcation observed during the ductoscopy insertion process provided in this embodiment of the invention. 1. Ductoscopy; 2. Sutures; 3. Hook needle; 4. Duct wall; 5. Tumor; 6. Duct lumen; 7. Lesion. Detailed Implementation

[0011] To enable those skilled in the art to better understand the present invention, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings.

[0012] In some of the processes described in the specification, claims, and accompanying drawings of this invention, multiple operations appearing in a specific order are included. However, it should be clearly understood that these operations may not be executed in the order they appear herein, or may be executed in parallel. The operation numbers, such as 101, 102, etc., are merely used to distinguish different operations and do not represent any execution order. Furthermore, these processes may include more or fewer operations, and these operations may be executed sequentially or in parallel. It should be noted that the descriptions such as "first," "second," etc., in this document are used to distinguish different messages, devices, modules, etc., and do not represent a sequential order, nor do they limit "first" and "second" to different types.

[0013] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0014] Figure 1 This is a schematic diagram of a system for locating intraductal lesions of the breast based on PROLENE sutures, provided in an embodiment of the present invention. Specifically, it includes: The ductoscope insertion module 201 is configured to insert a ductoscope into a mammary duct and reach the lesion area, with a cannula attached to the mammary duct. The suture insertion module 202 is configured to pass one end of the suture through the side hole of the cannula, so that one end of the suture reaches the lesion area; wherein, the cannula of the ductoscope has a side hole, which is a channel for the irrigation fluid or positioning hook to enter. In some embodiments, the suture insertion module further includes, after one end of the suture reaches the lesion area, a first distance beyond the distal end of the lesion, the first distance ranging from 0.5cm to 1.5cm; preferably, the first distance ranging from 0.5cm to 1cm.

[0015] In some embodiments, PROLENE sutures can be classified into different types according to their roughness and subdivision. In this embodiment, 5-0 PROLENE sutures, also known clinically as PROLENE sutures, can be used.

[0016] The suture insertion distance marker module 203 is configured to identify the first position of the exposed suture section outside the cannula, output a prompt message indicating that a distance marker is set at the first position, and measure the distance from the distance marker to the nipple; In some embodiments, the distance marker is a scale mark or an identifiable physical marker.

[0017] In some embodiments, the method for measuring the distance from the distance marker to the nipple is as follows: when the suture reaches the lesion within the mammary duct, the suture is fixed, and the distal end of the suture is cut at a predetermined distance from the nipple. The predetermined distance from the exposed suture end to the nipple is used as the distance from the marker to the nipple. Alternatively, the suture has graduations on its outer side, and the distance from the marker to the nipple is measured using these graduations. In a more specific embodiment, the predetermined distance is set to 10 cm, but in actual clinical practice, the predetermined distance can be set according to needs or habits.

[0018] The ductoscope withdrawal module 204 is configured to withdraw the ductoscope and cannula while observing the ductoscope's field of view, so that the suture is positioned around the lesion area and does not come out with the cannula. The distance correction module 205 is configured to identify the current position of the distance mark on the suture after the ductoscope and cannula are removed, determine whether the current position is consistent with the first position, and if they are inconsistent, adjust the distance mark to the first position.

[0019] In some embodiments, the method for determining whether the current position is consistent with the first position is as follows: When the PROLENE suture reaches the lesion within the mammary duct, the assistant fixes the suture with their left hand and cuts the distal end of the suture 10cm from the nipple with their right hand. The exposed suture end is fixed 10cm from the nipple, and this suture end is marked as the first position, serving as the distance from the mark to the nipple. After removing the endoscope, the distance between the exposed suture end and the nipple is measured. If the distance is 10cm, it indicates that the positioning line has not shifted, and the current position is determined to be consistent with the first position. In a more specific embodiment, the preset distance is set to 10cm, but in actual clinical practice, the preset distance can be set according to needs or habits.

[0020] In some embodiments, in the ductoscope withdrawal module, when withdrawing the ductoscope and cannula, the suture is positioned around the lesion area by simultaneously pushing the suture in the direction of the lesion area.

[0021] In some embodiments, the system further includes: a postoperative adjustment module configured to control an examination device to check and confirm the placement of the ductoscope and sutures; It is also configured to adjust the placement position in response to the offset of the placement position being greater than a preset offset threshold, so that the placement position of the ductoscope and suture is aligned with the expected placement point.

[0022] In some embodiments, the system further includes an installation navigation system, the installation navigation system comprising: The step-by-step guidance module is configured to provide real-time prompts for the sequence of surgical steps; The operation monitoring unit is configured to acquire surgical field image data via an image monitoring device; The early warning module is configured to generate early warning information and trigger audible and visual alerts in response to the triggering of early warning conditions; The processing module is configured as follows: Based on the surgical field image data, the instrument position and lesion characteristics within the surgical field are tracked and obtained; Based on the instrument location and lesion characteristics, the surgical steps are updated and displayed to the user based on the step guidance module.

[0023] In some embodiments, the subject of the operation herein refers to any animal (e.g., a mammal), including but not limited to humans, non-human primates, rodents, etc., which will become the recipient of a specific treatment. Preferably, the subject is a human.

[0024] The second aspect of this application discloses a device for locating intraductal lesions of the breast based on PROLENE sutures. The device includes: one or more processors and a memory; the memory is used to store one or more computer programs; when the one or more computer programs are executed by the one or more processors, the following steps are performed: By retrieving the computer program from the memory and using the processor to perform S101, the ductoscope is inserted into the mammary duct and reaches the lesion area, with a cannula attached to the mammary duct. By retrieving the computer program from the memory and using the processor to perform S102, one end of the suture is passed through the side hole of the cannula, so that one end of the suture reaches the lesion area. By retrieving the computer program from the memory and using the processor to perform S103, the first position of the exposed suture segment outside the cannula is identified, a prompt message indicating that a distance marker is set at the first position is output, and the distance from the distance marker to the nipple is measured. By retrieving the computer program from the memory and using the processor to perform S104, the ductoscope and cannula are withdrawn while observing the field of view of the ductoscope, so that the suture is positioned around the lesion area and does not come out with the cannula. By retrieving the computer program from the memory and using the processor to perform S105, after exiting the ductoscope and cannula, the current position of the distance mark on the suture is identified, and it is determined whether the current position is consistent with the first position. If they are inconsistent, the distance mark is adjusted to the first position.

[0025] In some embodiments, after one end of the suture reaches the lesion area, the step further includes: crossing a first distance from the distal end of the lesion, the first distance ranging from 0.5cm to 1.5cm.

[0026] In some embodiments, the device includes: a ductoscope and PROLENE sutures; wherein the ductoscope includes a mammary duct endoscope and a cannula.

[0027] In one embodiment, the system does not involve direct surgical procedures on the human body. The system operates in common clinical surgical modes and / or robot-assisted modes (in which the system utilizes a multi-degree-of-freedom end effector to perform delicate manipulations within the nipple and surrounding tissue structures), and achieves automated and / or semi-automated motion execution through computer instructions or programs and hardware control. The automated and / or semi-automated motion execution of the surgical robot is achieved solely through computer instructions or programs and hardware control. In this embodiment, the system deployment primarily includes two methods: built-in deployment and external deployment to control the execution of each unit. Built-in deployment: Integrated into the central processor of the surgical robot, serving as a core functional module of the robot control system; External deployment: As an independent control system, it interacts with surgical robots / robotic arms through standardized data interfaces.

[0028] In a fully automated process, the surgical robot autonomously completes the entire process control, including image data acquisition, recognition, and suturing, based on preset computer instructions or program sets. Specifically, this includes: The image acquisition unit acquires real-time image data of the surgical area, the image recognition unit automatically identifies the lowest point, endpoints and other feature points of the target suturing area, the computing unit calculates the optimal needle insertion angle, needle insertion distance and other motion parameters according to the preset algorithm, and the control unit sends motion commands to the robot / robotic arm to execute the fully automatic suturing operation.

[0029] In semi-automated processes, robots or robotic arms perform semi-automated process control under the guidance of doctors or other medical staff, specifically including: Image recognition and data transmission: The system uses the image recognition unit to identify and locate the lowest point and each endpoint in the real-time image, and synchronously transmits the coordinates of the feature points and image data to the display device of the doctor's operating terminal; Manual verification and parameter adjustment: Medical staff view real-time images and feature points through display devices to determine whether the coordinates of the points need to be adjusted; if adjustment is needed, they input correction parameters through the input interface of the operating terminal (such as touch screen, keyboard and mouse, voice commands); if no adjustment is needed, they input the command to continue the operation through the input interface of the operating terminal (such as touch screen, keyboard and mouse, voice commands). Parameter calculation and command generation: After receiving the corrected parameters, the system automatically recalculates motion parameters such as needle insertion angle and needle insertion distance, and generates new control commands; Closed-loop verification and confirmation: The system feeds back the corrected parameters and simulated motion path to the display device. After the medical staff confirms that there are no errors, they send an execution command to the system. Robotic arm execution: The robot / robotic arm receives the final control command and performs precise suturing operations.

[0030] To more clearly illustrate how PROLENE sutures, under the guidance of FDS, aid in the localization of intraductal lesions and facilitate pathological sampling, thereby improving subsequent accurate diagnosis and treatment, this example retrospectively studies 103 patients with PND (aged 26-78 years) who had a history of breastfeeding, as detailed below: method: The duration of PND leakage ranged from 7 days to 2 years. All patients visited our surgical clinic between June 2017 and October 2019 and underwent ductoscopy. All patients underwent breast ultrasound and breast MRI before ductoscopy. Other causes of PND, such as hyperprolactinemia and inflammatory processes, were ruled out by laboratory tests. Open biopsy was performed after positive results were observed. This study included 75 patients diagnosed with space-occupying lesions by ductoscopy. Each patient signed an informed consent form agreeing to undergo ductoscopy, ductoscopic localization using PROLENE sutures, and biopsy. Patients were divided into two groups based on whether or not PROLENE sutures were used (at the patient's discretion). This procedure utilized a ductoscope manufactured by Schölly Fiberoptic GMBH (Denzlingen, Germany; breast ductoscope, flexible, 0.35 × 160 mm; cannula, working length 90 mm, diameter 0.9 mm; 3CCD camera, PAL channel, endoscopic coupler). The working channel could accommodate tools such as guidewires. When the tumor was clearly visible on the ductoscopy image, its location, depth from the duct opening, quadrant, morphology, bleeding, and size of the lesion base were recorded. Then, with the patient's consent, a 5-0 PROLENE suture was placed next to the lesion.

[0031] Surgical steps: The patient was placed in a supine position. The nipple and areola were cleaned with povidone-iodine solution, and ductoscopy was performed under local anesthesia and diluted lidocaine (0.5%). First, a blunt needle with a diameter of 0.1 mm was inserted into the overflowing duct opening. Then, a dilator system was introduced into the duct opening to gently dilate the duct. Finally, a fiberscope was inserted to observe the duct lumen and flush the branch ducts with normal saline. If the lesion protruded outward and the lens could not pass through, solitary papilloma, multiple papilloma, intraductal papilloma lesions, or surface abnormalities were all considered positive findings during ductoscopy. The location of the mass was recorded as R3Ⅱ→4. With the patient's consent, a 5-0 PROLENE suture was passed through the cannula to the lesion site. An assistant fixed the distal end of the suture and measured the distance from the exposed suture end (marked with a marker pen) to the nipple. The scope was withdrawn while observing to ensure that the suture was not pulled out.

[0032] After general anesthesia via intravenous route, the surgical site was disinfected, draped with sterile gauze, the areola was incised, and the mammary ducts beneath the nipple-areola complex were located for total lobectomy. All excised tissues were sent for histological examination.

[0033] Pathological analysis: Tissue was fixed using 4% neutral buffered formalin and sectioned from the center outwards, then embedded in continuous transverse sections and stained with hematoxylin and eosin. Pathologists examined the fixed specimens and cut the tissue into 3 μm thick slices perpendicular to the long axis of the mammary ducts. Purple PROLENE sutures served as a good indicator for pathological diagnosis. Two pathologists simultaneously marked and manipulated the tissue. Examination results were classified into ductal hyperplasia, solitary papilloma, papillomatosis, ductal carcinoma in situ (DCIS), papilloma with invasive ductal carcinoma (IDC), mastopathy, and cystic hyperplasia.

[0034] Data and statistics: Mammography (MG) and ultrasound (US) results were classified using the Breast Imaging Reporting and Data System (BIRADS), with normal results graded as BIRADS 0-3 and abnormal results as BIRADS 4-5. Since all patients underwent open biopsies, this application aimed to determine how PROLENE suture localization improves the diagnostic accuracy of intraductal lesions. Data were analyzed using SPSS version 25.0 (IBM Chicago JSA), with chi-square tests used to analyze the following variables: patient age, duration of nipple discharge, discharge color, whether the discharge was spontaneous, and pathological diagnosis. Univariate analysis was used to assess the association between intraductal papillary lesions and all latent variables, followed by multivariate analysis for significant variables. The association between visual description and histopathological findings of the lesions was quantified by calculating the odds ratio and its 95% confidence interval for each variable.

[0035] result: Fifty-five patients complained of left-sided nipple discharge, and 48 complained of right-sided nipple discharge. The duration of unilateral nipple discharge ranged from 7 days to 2 years, with a mean duration of 6.05 months. Based on physical examination results, patients were divided into two groups: a non-bloody discharge group (12 cases, 11.6%) and a bloody discharge group (91 cases). Except for patients with obstructive malignant lesions, all patients underwent ultrasound and mammography. Mammography did not reveal any definite mass, showing only BIRADS 2 or 3 (48.3%). In 68 patients with ductal ectasia, 66.4% showed abnormalities on ultrasound, and malignancy was not considered before ductoscopy.

[0036] Studies show that patients with bloody nipple discharge are more likely to develop intraductal papillary lesions compared to those with non-bloody nipple discharge, and the characteristics and spontaneity of nipple discharge are independent factors associated with the degree of malignancy.

[0037] 103 patients with unilateral nipple discharge underwent ductoscopy, and papillary lesions were detected in 75 patients. All patients with space-occupying lesions signed informed consent forms for PROLENE suture placement and biopsy. A total of 49.3% (37 / 75) of patients consented to PROLENE suture placement. All 75 intraductal lesions were excised, and final pathological results were obtained. Based on ductoscopy and final pathological results, the intraductal tumor detection rate was 72.8%, and the malignant tumor detection rate was 4%. Ductostomy examination of patients with unilateral nipple discharge revealed 32 cases of solitary papilloma, 26 cases of multiple papilloma, 10 cases of papillomatosis, and 7 cases of irregular lesions. All lesions were surgically removed. Histopathological examination revealed that 5 patients had papillomatosis, 39 had solitary papilloma, 16 had multiple papilloma, 3 had ductal carcinoma in situ (DCIS), 4 had breast disease, and 8 had cystic hyperplasia.

[0038] Among patients who underwent PROLENE suture placement, 3 had papillomatosis, 19 had solitary papilloma, 12 had multiple papilloma, 2 had DCIS, and 1 had cystic hyperplasia. Following PROLENE suture placement under ductoscopy guidance, histopathological examination revealed lesions in 97.3% (36 / 37) of cases. Among patients who did not undergo PROLENE suture placement, 4 were diagnosed with breast disease, 7 with cystic hyperplasia, 3 with papillomatosis, 18 with solitary papilloma, 5 with multiple papilloma, and 1 with DCIS; histopathological examination did not detect lesions in 28.9% (11 / 38) of these cases.

[0039] In this study, PROLENE sutures were used only to locate and guide lesion finding. Intraductal lesions are small, making postoperative pathological examination difficult. The use of a fixation hook was primarily for more precise lesion detection, characterization, and guidance of clinical treatment. However, hooks are expensive and may pose risks of injury, bleeding, or even metastasis if the lesion is malignant. PROLENE sutures are commonly used surgical sutures, readily available, inexpensive, and non-invasive. This modified method for fixing intraductal lesions was discovered during clinical practice. It solves practical problems, is more readily available, cost-effective, and highly practical, expanding the clinical applications of PROLENE surgical sutures.

[0040] The exemplary embodiments of this disclosure described in detail above are merely illustrative and not restrictive. Those skilled in the art will understand that various modifications and combinations can be made to these embodiments or their features without departing from the principles and spirit of this disclosure, and such modifications should fall within the scope of this disclosure.

Claims

1. A system for locating intraductal lesions of the breast based on PROLENE sutures, characterized in that, include: The ductoscope insertion module is configured to insert a ductoscope into the mammary duct and reach the lesion area, with a cannula attached to the mammary duct. The suture insertion module is configured to pass one end of the suture through the side hole of the cannula, so that one end of the suture reaches the lesion area. The suture insertion distance marker module is configured to identify the first position of the exposed suture section outside the cannula, output a prompt message indicating that a distance marker is set at the first position, and measure the distance from the distance marker to the nipple; The ductoscope withdrawal module is configured to withdraw the ductoscope and cannula while observing the ductoscope field of view, so that the suture is positioned around the lesion area; The distance correction module is configured to, after the ductoscope and cannula are removed, identify the current position of the distance mark on the suture, determine whether the current position is consistent with a first position, and if not, adjust the distance mark to the first position.

2. The system for locating intraductal lesions of the breast based on PROLENE sutures according to claim 1, characterized in that, In the suture insertion module, after one end of the suture reaches the lesion area, it further includes: crossing the distal end of the lesion by a first distance, the first distance ranging from 0.5cm to 1.5cm; the first distance is preferably 0.5-1cm.

3. The system for locating intraductal lesions of the breast based on PROLENE sutures according to claim 2, characterized in that, The distance marker is a scale mark or an identifiable physical marker.

4. The system for locating intraductal lesions of the breast based on PROLENE sutures according to claim 3, characterized in that, The method for determining whether the current position is consistent with the first position is as follows: when the suture reaches the lesion in the mammary duct, the suture is fixed and the distal end of the suture is cut at a preset distance from the nipple. The suture cut end of the exposed part of the breast is fixed at a preset distance from the nipple, and the suture cut end is marked as the first position as the distance from the mark to the nipple. After removing the ductoscope and cannula, measure the distance between the exposed suture end and the nipple. If the distance is still the preset distance, it indicates that the suture has not shifted, and the current position is determined to be consistent with the first position. Optionally, the method for measuring the distance from the distance marker to the nipple is as follows: when the suture reaches the lesion inside the mammary duct, the suture is fixed and the distal end of the suture is cut at a preset distance from the nipple. The preset distance from the exposed suture end to the nipple is used as the distance from the marker to the nipple. Alternatively, the suture is provided with a scale on the outside, and the distance from the distance marker to the nipple is measured by the scale of the suture.

5. The system for locating intraductal lesions of the breast based on PROLENE sutures according to claim 1, characterized in that, In the ductoscope withdrawal module, when withdrawing the ductoscope and cannula, the suture is positioned around the lesion area by simultaneously pushing the suture in the direction of the lesion area.

6. The system for locating intraductal lesions of the breast based on PROLENE sutures according to claim 1, characterized in that, The system also includes a postoperative adjustment module, configured to control the examination equipment to check and confirm the placement of the ductoscope and sutures; It is also configured to adjust the placement position in response to the offset of the placement position being greater than a preset offset threshold, so that the placement position of the ductoscope and suture is aligned with the expected placement point.

7. The system for locating intraductal lesions of the breast based on PROLENE sutures according to any one of claims 1-6, characterized in that, The system also includes an installation navigation system, the installation navigation system comprising: The step-by-step guidance module is configured to provide real-time prompts for the sequence of surgical steps; The operation monitoring unit is configured to acquire surgical field image data via an image monitoring device; The early warning module is configured to generate early warning information and trigger audible and visual alerts in response to the triggering of early warning conditions; The processing module is configured as follows: Based on the surgical field image data, the instrument position and lesion characteristics within the surgical field are tracked and obtained; Based on the instrument location and lesion characteristics, the surgical steps are updated and displayed to the user based on the step guidance module.

8. A device for locating intraductal lesions of the breast based on PROLENE sutures, characterized in that, The device includes: one or more processors and a memory; the memory is used to store one or more computer programs; when the one or more computer programs are executed by the one or more processors, the following steps are performed: S101, inserting a ductoscope into the mammary duct and reaching the lesion area, with a cannula attached to the mammary duct; S102, pass one end of the suture through the side hole of the cannula so that one end of the suture reaches the lesion area; S103, identify the first position of the exposed suture section outside the cannula, output a prompt message indicating that a distance mark is set at the first position, and measure the distance from the distance mark to the nipple; S104, while observing the field of view of the ductoscope, withdraw the ductoscope and cannula so that the suture is positioned around the lesion area; S105, after removing the ductoscope and cannula, identify the current position of the distance mark on the suture, and determine whether the current position is consistent with the first position. If they are inconsistent, adjust the distance mark to the first position.

9. The device for locating intraductal lesions of the breast based on PROLENE sutures according to claim 8, characterized in that, After one end of the suture reaches the lesion area, the step further includes: crossing a first distance from the distal end of the lesion, the first distance ranging from 0.5cm to 1.5cm.

10. The device for locating intraductal lesions of the breast based on PROLENE sutures according to claim 8, characterized in that, The device includes: a ductoscope and PROLENE sutures; wherein the ductoscope includes a mammary duct endoscope and a cannula.

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