ERCP intubation navigation system and method based on indocyanine green fluorescence imaging

Abstract

The invention provides an ERCP intubation navigation system and method based on indocyanine green fluorescence imaging. The ERCP intubation navigation system based on indocyanine green fluorescence imaging comprises an ICG injection module, a fluorescence endoscope acquisition module, an ERCP intubation module, an operation control module, an image signal processing module and a navigation display module, the ICG injection module is a preoperative fluorescent target preparation unit and is used for injecting an indocyanine green contrast agent into the vein of a patient, so that the contrast agent is enriched at an opening of a duodenal papilla biliary tract along with bile after being taken by hepatocytes, and a targeted biological target for system fluorescent imaging is formed. According to the ERCP intubation navigation system and method based on indocyanine green fluorescence imaging, the diversified clinical operation requirements of ERCP intubation are met, the safety of clinical use of the system is improved through the design of the standby power interface, the overall operation response of the system is rapid, the operation time can be effectively shortened, the repeated trial insertion frequency is reduced, the discomfort of a patient in an operation is reduced, and the operation efficiency is improved. And the manpower and time cost of clinical operation is reduced.

Description

Technical Field

[0001] This invention relates to the fields of medical devices and clinical medicine, and in particular to an ERCP cannulation navigation system and method based on indocyanine green fluorescence imaging. Background Technology

[0002] ERCP is a core minimally invasive technique for diagnosing and treating biliary and pancreatic diseases. The key to its success lies in the selective deep cannulation of the bile duct or pancreatic duct. Currently, routine ERCP cannulation procedures lack dedicated visual navigation systems and rely primarily on the physician's clinical experience and X-ray fluoroscopy feedback for exploratory cannulation. This makes it impossible to observe the anatomical structures of the duodenal papilla in real time. For difficult cases such as papilla variations or peridiverticulum papillae, the cannulation failure rate remains high. Furthermore, repeated unintentional insertion of cannulation instruments into the pancreatic duct and injection of contrast agents is the most significant factor in inducing postoperative pancreatitis, severely limiting the clinical safety of ERCP procedures. The frequent use of X-ray fluoroscopy throughout the procedure results in cumulative radiation damage to both doctors and patients, posing long-term health risks. Repeated trial insertions significantly prolong the operation time, increase patient discomfort during the procedure, and raise the human and time costs of clinical operations.

[0003] Indocyanine green, a routinely used clinical drug for liver function diagnosis, has the characteristics of specific uptake by hepatocytes, excretion into bile unchanged, non-participation in enterohepatic circulation, a half-life of only 3-4 minutes, rapid metabolism with no residue, and the ability to generate stable near-infrared fluorescence signals at a wavelength of about 800nm ​​under near-infrared light excitation at a wavelength of 700-900nm. Near-infrared fluorescence imaging technology has been maturely applied in surgical fluorescence laparoscopic surgery. Its principle is to generate fluorescence signals by exciting fluorescent contrast agents with near-infrared light sources, and then achieve visualization of target tissues after filtering, imaging, and processing. However, current technology has not yet integrated this technology with ERCP duodenoscopes, nor is there a standardized usage method adapted to such integrated systems, which cannot solve the core technical pain points of traditional ERCP cannulation.

[0004] Current routine ERCP cannulation techniques have several significant drawbacks: High degree of blindness in the cannulation process: Operators rely primarily on personal clinical experience and X-ray fluoroscopy feedback for exploratory cannulation, making it impossible to observe the anatomical structures within the duodenal papilla in real time. For challenging cases such as papilla variations or peridiverticulum papillae, the cannulation failure rate remains high. High risk of postoperative complications: Repeated unintentional insertion of cannulation instruments into the pancreatic duct and injection of contrast agents is the leading cause of postoperative pancreatitis, severely limiting the clinical safety of ERCP procedures. Radiation exposure issues for both physicians and patients: Frequent X-ray fluoroscopy throughout the procedure exposes both physicians and patients to cumulative radiation damage, posing long-term health risks. Low operational efficiency: Repeated trial insertions prolong the operation time, increase patient discomfort, and raise the human and time costs of clinical procedures.

[0005] Therefore, it is necessary to provide an ERCP cannulation navigation system and method based on indocyanine green fluorescence imaging to solve the above-mentioned technical problems. Summary of the Invention

[0006] This invention provides an ERCP cannulation navigation system and method based on indocyanine green fluorescence imaging, which solves the problems of high blindness in traditional ERCP cannulation, high risk of postoperative pancreatitis, radiation exposure for medical staff and patients, and low operation efficiency.

[0007] To solve the above-mentioned technical problems, the ERCP cannulation navigation system and method based on indocyanine green fluorescence imaging provided by the present invention includes: an ICG injection module, a fluorescence endoscope acquisition module, an ERCP cannulation module, an operation control module, an image signal processing module, and a navigation display module; The ICG injection module is a preoperative fluorescent target preparation unit used to inject indocyanine green contrast agent into the patient intravenously. After being taken up by hepatocytes, the contrast agent is enriched in the bile at the opening of the duodenal papilla, forming a targeted biological target for systematic fluorescence imaging. The fluorescence endoscope acquisition module is the core hardware for image and signal acquisition of the system. It is used to acquire ordinary white light images and near-infrared fluorescence images of the duodenal region, and at the same time emits a near-infrared laser to excite indocyanine green to generate a specific near-infrared fluorescence signal. The ERCP cannulation module includes conventional ERCP cannulation instruments such as guidewires, duodenal papilla incision knives, and contrast tubes, which are inserted via a fluorescence endoscope acquisition module to complete the cannulation operation. The operation control module is the core of the system's command input and equipment control. It is linked with the fluorescence endoscope acquisition module and the image signal processing module to control the switching of imaging modes, the adjustment of near-infrared light source intensity, and the auxiliary control of water and gas injection in conjunction with ERCP cannulation operations. The image signal processing module is the core hardware for data analysis and processing of the system. It is used to receive the raw images and signals transmitted by the fluorescence endoscope acquisition module, process them by the algorithm to generate real-time fluorescence navigation images, and at the same time complete the spatial positioning of the bile duct opening center and the extraction of cannulation path guidance parameters. The navigation display module is the core hardware for image and parameter output of the system. It is used to output fused fluorescence navigation images and cannulation path guidance parameters in real time, and dynamically present the highlighted bile duct opening and surrounding anatomical structures. The ICG injection module requires complete dissolution of indocyanine green with water for injection, prepared at a dose of 0.2-0.5 mg / kg body weight, and slowly injected via the patient's forearm vein 30-60 minutes before ERCP procedure. Observe for 5 minutes after injection to confirm the absence of adverse reactions such as allergies or fever. The fluorescence endoscopy acquisition module requires pre-sterilization, checking the flexibility of the insertion section, the integrity of the tip cap, and the sealing of each interface. After activation, it defaults to white light imaging mode, and the intensity of the near-infrared laser light source is adjusted to the initial level. The ERCP cannulation module requires the selection of guidewires, nipple incision knives, and other instruments that are compatible with the biopsy channel interface specifications. Check the patency and operability of the instruments to avoid intraoperative jamming. The operation control module requires confirmation that mode switching, light source adjustment, and water and gas injection control functions are normal, and that dual control logic is synchronously effective. The image signal processing module requires algorithm self-checking to confirm that noise reduction, fluorescence enhancement, and image fusion functions are normal, and that backup power is sufficient. The navigation display module requires adjusting the screen angle and brightness to a suitable state, confirming synchronous image output from the fixed display terminal and portable display terminal, and that the image magnification and freeze functions can be called normally. The hardware modules and functional units, including fluorescence imaging acquisition, signal processing and analysis, operation command control, and navigation image display, utilize the hepatobiliary-specific metabolic characteristics of indocyanine green combined with near-infrared fluorescence imaging technology to achieve real-time visual navigation within the endovascular space for ERCP cannulation. This solves the technical problems of high blindness in traditional ERCP cannulation, high risk of postoperative pancreatitis, radiation exposure for both medical staff and patients, and low operational efficiency. The ERCP cannulation navigation system based on indocyanine green fluorescence imaging provided by this invention significantly improves cannulation accuracy and first-time success rate, reduces the incidence of complications and radiation exposure, is easy to operate, has strong compatibility, and can be directly adapted to routine ERCP clinical operation procedures, especially suitable for cases with difficult cannulation. Indocyanine green is a green powder, soluble in water and methanol, but practically insoluble in most organic solvents. After intravenous injection, it binds to plasma albumin, is specifically taken up by hepatocytes, and is excreted unchanged into the bile. It does not participate in enterohepatic circulation or renal excretion, and has a half-life of only 3-4 minutes, resulting in rapid metabolism and no residue in the body. Based on these metabolic characteristics, clinically, its plasma clearance rate and 15-minute retention rate can be used to quantitatively assess effective hepatic blood flow, total number of functional hepatocytes, and biliary patency. It can also be used to examine and measure circulatory system functions such as cardiac output and mean circulation time. Before use, it must be fully dissolved in water for injection and administered intravenously at a dose of 0.2-0.5 mg / kg. Before use, ensure the preparation is completely dissolved to avoid adverse reactions such as nausea, fever, shock, or allergic reactions. Close monitoring of the patient's vital signs is necessary from injection until the end of the examination.

[0008] Preferably, the operation control module includes a mode switching unit, a light source adjustment unit, and an auxiliary operation unit. The mode switching unit is used to support real-time seamless switching between fluorescence imaging mode and white light imaging mode. The light source adjustment unit realizes multi-level adjustable near-infrared light source intensity. The auxiliary operation unit realizes quantitative and continuous dual-mode adjustable water injection and gas injection control.

[0009] Preferably, the fluorescence endoscope acquisition module includes an acquisition main unit, a laser emission unit, an image sensing unit, a protection unit, an operation control unit, an instrument access unit, a signal connection unit, and a media connection unit. The acquisition main unit is a side-viewing duodenoscope modified with integrated near-infrared fluorescence function, including an insertion part, an operation part, and a connection part. The laser emission unit is a near-infrared laser source emission window integrated at the front end of the insertion part of the acquisition main unit. The image sensing units are all integrated at the front end of the insertion part of the acquisition main unit, and the insertion part of the acquisition main unit is encapsulated with signal transmission cables and auxiliary channel pipelines.

[0010] Preferably, the protective unit is a tip cap made of transparent medical polymer material, located at the front end of the insertion part of the acquisition main unit. It can transmit near-infrared laser and fluorescence signals and is adapted to the bending angle adjustment of the insertion part. The insertion part also integrates an optical fiber transmission line, which is connected to the near-infrared laser source emission window of the laser emission unit to achieve stable transmission and emission of near-infrared laser. The operation control unit is integrated into the operation part of the acquisition main unit, including an angle control knob, a mode switching button, and a light source intensity adjustment button. The instrument access unit is a biopsy channel interface, located in the operation part of the acquisition main unit, and is compatible with various intubation instruments of the ERCP intubation module. The signal connection unit is a general signal interface, and the medium connection unit is an auxiliary channel interface, both located in the connection part of the acquisition main unit, respectively realizing the signal connection with the image signal processing module and the medium connection with the external water injection and gas injection equipment.

[0011] Preferably, the image signal processing module includes a hardware processing unit, an algorithm operation unit, a human-computer interaction unit, a signal transmission unit, and a wireless communication unit.

[0012] Preferably, the hardware processing unit is the core computing hardware, and the algorithm computing unit has built-in noise reduction algorithm, fluorescence enhancement algorithm, image fusion algorithm and spatial coordinate calculation algorithm, which can eliminate interference signals such as tissue scattering and equipment noise, improve the contrast of fluorescence signals, and accurately superimpose the fluorescence image on the corresponding position of the white light image in pseudo-color high brightness form to realize the image fusion display of fluorescence and white light modes. The human-computer interaction unit is an operation panel, which integrates mode switching key, light source adjustment key, image enhancement key and water injection and gas injection control key, forming dual control with the operation control unit key of the fluorescence endoscope acquisition module, which is adapted to clinical operation habits. The signal transmission unit is equipped with a signal receiving end, power interface, display output end and backup power interface to realize seamless switching of signal reception, equipment power supply and sudden power failure. The wireless communication unit is used to realize wireless signal transmission with the portable display terminal of the navigation display module.

[0013] Preferably, the navigation display module includes a display hardware unit and an image output unit. The display hardware unit is a high-definition medical display screen, which includes a fixed display device and a portable display device. It is connected to the signal transmission unit of the image signal processing module through wired and wireless dual communication methods. The image output unit supports image magnification, freeze, and playback functions, and can dynamically present fused navigation images, bile duct opening location coordinates, and intubation path guidance parameters in real time.

[0014] Preferably, the laser emitting unit includes a near-infrared laser source emitting window and a micro electric adjustment component. The micro electric adjustment component is rigidly connected to the near-infrared laser source emitting window and is encapsulated in the front end of the endoscope, which can realize stepless adjustment of the laser emission angle within the range of ±15°. The adjustment signal is transmitted through a dedicated channel and can be controlled by the operation control unit or the image signal processing module. The miniature electric adjustment component uses a medical miniature DC motor, and the power supply comes from the built-in battery of the fluorescence endoscope acquisition module.

[0015] Preferably, the image sensing unit includes a fluorescence image sensor, a white light imaging component, and an optical axis calibration module. The optical axis calibration module is integrated between the fluorescence image sensor and the white light imaging component and has a built-in micro-displacement adjustment mechanism, which can realize micron-level position compensation in the lateral and longitudinal directions. The built-in micro-displacement adjustment mechanism has a lateral and longitudinal position compensation accuracy of ≤±5μm.

[0016] A method for an ERCP cannulation navigation system based on indocyanine green fluorescence imaging, wherein the ERCP cannulation navigation system based on indocyanine green fluorescence imaging requires the use of this method during use, and includes the following steps: S1: Using the ICG injection module, 30-60 minutes before the ERCP procedure, the patient is intravenously injected with a dose of indocyanine green contrast agent of 0.2-0.5 mg / kg body weight. After the contrast agent reaches the liver through blood circulation, it is specifically taken up by hepatocytes, excreted unchanged into the bile, and transported sequentially to the intrahepatic bile ducts and extrahepatic bile ducts. Finally, it accumulates at the opening of the bile duct in the duodenal papilla, completing the specific fluorescent labeling of the biliary system and forming the targeted biological target for systemic fluorescence imaging. S2: Connect the ICG injection module, ERCP cannulation module, operation control module, fluorescence endoscopy acquisition module, image signal processing module, and navigation display module through a dedicated interface. Turn on the system and switch to white light imaging mode by default. Adjust each module to normal working condition. Hold the acquisition main unit of the fluorescence endoscopy acquisition module and slowly insert its insertion part into the patient's body. Adjust the bending angle of the front end of the insertion part by operating the angle control knob of the operation control unit. Precisely position the fluorescence endoscopy acquisition module to the duodenal papilla area through the real-time white light image displayed by the navigation display module. S3: Fluorescence Mode Activation and Signal Excitation: By using the mode switching button on the operation control unit of the fluorescence endoscope acquisition module or the mode switching button on the human-computer interaction unit of the image signal processing module, the system is switched to fluorescence imaging mode via the mode switching unit of the operation control module. The emission intensity of the near-infrared light source is adjusted by the light source adjustment unit, so that the laser emission unit of the fluorescence endoscope acquisition module emits a near-infrared laser with a wavelength of 700-900nm. The laser penetrates the tip cap of the insertion part protection unit and irradiates the duodenal papilla region, exciting the indocyanine green enriched at the bile duct opening to generate a specific near-infrared fluorescence signal with a wavelength of about 800nm. S4: Image Acquisition and Fusion Processing: In the image sensing unit of the fluorescence endoscope acquisition module, the fluorescence image sensor synchronously acquires the original near-infrared fluorescence image of the nipple region after filtering out interference light through a near-infrared filter. The white light imaging component synchronously acquires the original white light image of the same region. The two original images are transmitted in real time to the signal receiving end of the signal transmission unit of the image signal processing module through the signal transmission cable encapsulated inside the insertion section. The algorithm processing unit of the image signal processing module first removes interference signals such as tissue scattering and equipment noise through a noise reduction algorithm, then enhances the contrast of the fluorescence signal through a fluorescence enhancement algorithm. Subsequently, the processed fluorescence image is accurately superimposed on the corresponding position of the white light image in a pseudo-color high-brightness form through an image fusion algorithm to generate a fused fluorescence navigation image. At the same time, the spatial coordinate calculation algorithm is used to locate the center position of the bile duct opening and extract the cannulation path guidance parameters. S5: Fluorescence-guided targeted cannulation: The image signal processing module transmits the fused fluorescence navigation image and cannulation path guidance parameters to the navigation display module in real time via the signal transmission unit display output terminal and the wireless communication unit. The physician can clearly identify the highlighted bile duct fluorescence channel through the display hardware unit of the navigation display module, and distinguish the bile duct opening from the pancreatic duct opening based on the difference in fluorescence imaging. The cannulation instrument of the ERCP cannulation module is sent in through the instrument access unit of the fluorescence endoscope acquisition module and extends out through the working channel outlet of the insertion part. Under the real-time guidance of the fused fluorescence navigation image, the cannulation instrument is slowly advanced so that the instrument is accurately inserted into the fluorescently marked common bile duct opening. If the surgical field is blurred, the water injection and air injection functions are activated through the auxiliary operation unit of the operation control module to clear the surgical field and ensure smooth cannulation operation. S6: Intubation Verification and Subsequent Operations: After the intubation instrument is inserted into the common bile duct, a brief X-ray fluoroscopy scan can be used to help confirm the precise position of the intubation instrument in the bile duct. After confirmation, the physician can flexibly switch between white light and fluorescence imaging modes through the mode switching unit of the operation control module according to the needs of the surgery, and complete subsequent ERCP-related operations such as sphincterotomy, stone removal, and angiography. The status of the bile duct area can be monitored in real time through the navigation display module throughout the operation.

[0017] Compared with related technologies, the ERCP cannulation navigation system and method based on indocyanine green fluorescence imaging provided by this invention have the following advantages: This invention provides an ERCP cannulation navigation system and method based on indocyanine green fluorescence imaging. The invention integrates an ICG injection module, an ERCP cannulation module, an operation control module, a fluorescence endoscopy acquisition module, an image signal processing module, and a navigation display module. Each module has refined functional units and hardware units. Simultaneously, a standardized usage method tailored to the system hardware and the metabolic characteristics of indocyanine green is designed. The hepatobiliary-specific metabolic characteristics of indocyanine green provide specific fluorescent targets for the system, and near-infrared fluorescence imaging technology enables real-time visualization guidance within the ERCP cannulation lumen. This system transforms the traditional "blind probing" procedure into a "visual and precise operation," providing physicians with clear endoscopic landmarks and significantly improving the first-time success rate of cannulation. It is particularly suitable for cases with difficult cannulation, such as papillary variations or peridiverticulum papillae. Furthermore, the system can clearly distinguish between the bile duct opening and the pancreatic duct opening through fluorescence contrast, minimizing mechanical stimulation of the pancreatic duct by the ERCP cannulation module and reducing the risk of accidental injection of contrast agent. This fundamentally lowers the incidence of postoperative pancreatitis. Indocyanine green is a routinely used clinical diagnostic drug, metabolized rapidly, and radiation-free. The clearly defined contrast agent injection parameters in the usage instructions ensure high safety and require no additional clinical intervention. The system minimizes the risk of complications and significantly reduces the frequency and duration of X-ray fluoroscopy, thereby reducing cumulative X-ray radiation exposure for both patients and medical staff. Each module and unit is integrated and detachably connected. The usage steps are highly compatible with standard clinical ERCP procedures. The instrument access unit can directly adapt to standard ERCP cannulation instruments without drastically altering existing ERCP procedures. It exhibits strong compatibility with existing ERCP equipment, and its clear and convenient operation makes it easy for physicians to learn. The system hardware is compatible with clinical sterilization and operating room environments, facilitating widespread clinical application. Furthermore, the system supports both fixed and portable display devices, enabling wired and wireless communication. With dual control design and multi-parameter adjustable functions, system parameters can be flexibly adjusted based on different patients' fluorescence imaging effects, different operating table layouts, and varying operational needs, meeting diverse clinical ERCP cannulation requirements. The backup power interface enhances the system's clinical safety. The system's overall operation is responsive, effectively shortening surgical time, reducing repeated insertion attempts, minimizing patient discomfort, and reducing the manpower and time costs of clinical operations. Attached Figure Description

[0018] Figure 1 This is a schematic diagram of a first embodiment of the ERCP cannulation navigation system based on indocyanine green fluorescence imaging provided by the present invention; Figure 2 A schematic diagram of the operation control module is provided for this invention; Figure 3 A schematic diagram of the fluorescence endoscopy acquisition module provided for this invention; Figure 4A schematic diagram of the image signal processing module provided for this invention; Figure 5 A schematic diagram of the navigation display module provided for this invention; Figure 6 This is a schematic diagram of a second embodiment of the ERCP cannulation navigation system based on indocyanine green fluorescence imaging provided by the present invention; Figure 7 A schematic diagram of the image sensing unit provided for this invention. Detailed Implementation

[0019] The present invention will be further described below with reference to the accompanying drawings and embodiments. Example

[0020] Please refer to the following: Figure 1 , Figure 2 , Figure 3 , Figure 4 and Figure 5 ,in, Figure 1 This is a schematic diagram of a first embodiment of the ERCP cannulation navigation system based on indocyanine green fluorescence imaging provided by the present invention; Figure 2 A schematic diagram of the operation control module is provided for this invention; Figure 3 A schematic diagram of the fluorescence endoscopy acquisition module provided for this invention; Figure 4 A schematic diagram of the image signal processing module provided for this invention; Figure 5 A schematic diagram of the navigation display module is provided for this invention. The ERCP cannulation navigation system based on indocyanine green fluorescence imaging includes: an ICG injection module, a fluorescence endoscope acquisition module, an ERCP cannulation module, an operation control module, an image signal processing module, and a navigation display module; The ICG injection module is a preoperative fluorescent target preparation unit used to inject indocyanine green contrast agent into the patient intravenously. After being taken up by hepatocytes, the contrast agent is enriched in the bile at the opening of the duodenal papilla, forming a targeted biological target for systematic fluorescence imaging. The fluorescence endoscope acquisition module is the core hardware for image and signal acquisition of the system. It is used to acquire ordinary white light images and near-infrared fluorescence images of the duodenal region, and at the same time emits a near-infrared laser to excite indocyanine green to generate a specific near-infrared fluorescence signal. The ERCP cannulation module includes conventional ERCP cannulation instruments such as guidewires, duodenal papilla incision knives, and contrast tubes, which are inserted via a fluorescence endoscope acquisition module to complete the cannulation operation. The operation control module is the core of the system's command input and equipment control. It is linked with the fluorescence endoscope acquisition module and the image signal processing module to control the switching of imaging modes, the adjustment of near-infrared light source intensity, and the auxiliary control of water and gas injection in conjunction with ERCP cannulation operations. The image signal processing module is the core hardware for data analysis and processing of the system. It is used to receive the raw images and signals transmitted by the fluorescence endoscope acquisition module, process them by the algorithm to generate real-time fluorescence navigation images, and at the same time complete the spatial positioning of the bile duct opening center and the extraction of cannulation path guidance parameters. The navigation display module is the core hardware for image and parameter output of the system. It is used to output fused fluorescence navigation images and cannulation path guidance parameters in real time, and dynamically present the highlighted bile duct opening and surrounding anatomical structures. The ICG injection module requires complete dissolution of indocyanine green with water for injection, prepared at a dose of 0.2-0.5 mg / kg body weight, and slowly injected via the patient's forearm vein 30-60 minutes before ERCP procedure. Observe for 5 minutes after injection to confirm the absence of adverse reactions such as allergies or fever. The fluorescence endoscopy acquisition module requires pre-sterilization, checking the flexibility of the insertion section, the integrity of the tip cap, and the sealing of each interface. After activation, it defaults to white light imaging mode, and the intensity of the near-infrared laser light source is adjusted to the initial level. The ERCP cannulation module requires the selection of guidewires, nipple incision knives, and other instruments that are compatible with the biopsy channel interface specifications. Check the patency and operability of the instruments to avoid intraoperative jamming. The operation control module requires confirmation that mode switching, light source adjustment, and water and gas injection control functions are normal, and that dual control logic is synchronously effective. The image signal processing module requires algorithm self-checking to confirm that noise reduction, fluorescence enhancement, and image fusion functions are normal, and that backup power is sufficient. The navigation display module requires adjusting the screen angle and brightness to a suitable state, confirming synchronous image output from the fixed display terminal and portable display terminal, and that the image magnification and freeze functions can be called normally. The hardware modules and functional units, including fluorescence imaging acquisition, signal processing and analysis, operation command control, and navigation image display, utilize the hepatobiliary-specific metabolic characteristics of indocyanine green combined with near-infrared fluorescence imaging technology to achieve real-time visual navigation within the endovascular space for ERCP cannulation. This solves the technical problems of high blindness in traditional ERCP cannulation, high risk of postoperative pancreatitis, radiation exposure for both medical staff and patients, and low operational efficiency. The ERCP cannulation navigation system based on indocyanine green fluorescence imaging provided by this invention significantly improves cannulation accuracy and first-time success rate, reduces the incidence of complications and radiation exposure, is easy to operate, has strong compatibility, and can be directly adapted to routine ERCP clinical operation procedures, especially suitable for cases with difficult cannulation. The optical fiber transmission line, signal transmission cable, water injection line, and gas injection line encapsulated inside the insertion section of the fluorescence endoscopy acquisition module correspond to the near-infrared laser transmission, image signal transmission, and media transmission functions, respectively. This clarifies the one-to-one correspondence and division of labor among the three types of lines, filling the gap in the main document that only mentions the encapsulation of the lines without detailing their functions. In the image signal processing module, the hardware processing unit, as the core computing hardware, plays a fundamental role in ensuring the high-speed processing of various algorithms such as noise reduction and fluorescence enhancement in the algorithm computing unit, making the hardware support logic more rigorous. In the navigation display module, the fixed display device achieves data interaction with the image signal processing module through wired connection, while the portable display device achieves data interaction through wireless connection. At the same time, it is clarified that the display terminal supports flexible adjustment of screen angle and height to adapt to the actual clinical needs of different ERCP operating table layouts. The fluorescence endoscope acquisition module, image signal processing module, and navigation display module are detachably connected. The acquisition main unit of the fluorescence endoscope acquisition module adopts a medical sterile packaging design to meet the needs of clinical disinfection and reuse. The ICG injection module provides biliary fluorescence targets to the fluorescence endoscopy acquisition module. The ERCP cannulation module is inserted through the instrument access unit of the fluorescence endoscopy acquisition module and cannulation is completed under navigation guidance. The operation control module bidirectionally links the fluorescence endoscopy acquisition module and the image signal processing module to realize mode switching, light source adjustment, water injection, and gas injection control. The fluorescence endoscopy acquisition module acquires white light and fluorescence images and transmits them to the image signal processing module through the signal connection unit. The image signal processing module processes the images to generate a fused navigation map, which is transmitted to the navigation display module through the signal transmission unit / wireless communication unit. The navigation display module outputs real-time navigation images and cannulation parameters to provide physicians with visual guidance.

[0021] The operation control module includes a mode switching unit, a light source adjustment unit, and an auxiliary operation unit. The mode switching unit supports real-time seamless switching between fluorescence imaging mode and white light imaging mode. The light source adjustment unit enables multi-level adjustable intensity of near-infrared light source. The auxiliary operation unit enables quantitative and continuous dual-mode adjustable control of water injection and gas injection.

[0022] The fluorescence endoscope acquisition module includes an acquisition main unit, a laser emission unit, an image sensing unit, a protection unit, an operation control unit, an instrument access unit, a signal connection unit, and a media connection unit. The acquisition main unit is a side-viewing duodenoscope modified with integrated near-infrared fluorescence function, including an insertion part, an operation part, and a connection part. The laser emission unit is a near-infrared laser source emission window, integrated at the front end of the insertion part of the acquisition main unit. The image sensing units are all integrated at the front end of the insertion part of the acquisition main unit, and the insertion part of the acquisition main unit is encapsulated with signal transmission cables and auxiliary channel pipelines.

[0023] The protective unit is a cap made of transparent medical polymer material, located at the front end of the insertion part of the acquisition main unit. It can transmit near-infrared laser and fluorescence signals and is adapted to the bending angle adjustment of the insertion part. The insertion part also integrates an optical fiber transmission line, which is connected to the near-infrared laser source emission window of the laser emission unit to achieve stable transmission and emission of near-infrared laser. The operation control unit is integrated into the operation part of the acquisition main unit, including an angle control knob, a mode switching button, and a light source intensity adjustment button. The instrument access unit is a biopsy channel interface, located in the operation part of the acquisition main unit, and is compatible with various intubation instruments of the ERCP intubation module. The signal connection unit is a general signal interface, and the medium connection unit is an auxiliary channel interface, both located in the connection part of the acquisition main unit, respectively realizing the signal connection with the image signal processing module and the medium connection with external water injection and gas injection equipment.

[0024] The image signal processing module includes a hardware processing unit, an algorithm calculation unit, a human-computer interaction unit, a signal transmission unit, and a wireless communication unit.

[0025] The hardware processing unit is the core computing hardware. The algorithm computing unit has built-in noise reduction algorithm, fluorescence enhancement algorithm, image fusion algorithm, and spatial coordinate calculation algorithm. It can eliminate interference signals such as tissue scattering and equipment noise, improve the contrast of fluorescence signals, and accurately superimpose the fluorescence image on the corresponding position of the white light image in pseudo-color high brightness form to achieve image fusion display of fluorescence and white light modes. The human-computer interaction unit is an operation panel that integrates mode switching keys, light source adjustment keys, image enhancement keys, and water injection and gas injection control keys. It forms a dual control with the operation control unit of the fluorescence endoscope acquisition module, which is adapted to clinical operation habits. The signal transmission unit is equipped with a signal receiving end, a power interface, a display output end, and a backup power interface to achieve seamless switching between signal reception, equipment power supply, and sudden power failure. The wireless communication unit is used to achieve wireless signal transmission with the portable display terminal of the navigation display module.

[0026] The navigation display module includes a display hardware unit and an image output unit. The display hardware unit is a high-definition medical display screen, which includes a fixed display device and a portable display device. It is connected to the signal transmission unit of the image signal processing module through wired and wireless dual communication methods. The image output unit supports image magnification, freeze, and playback functions, and can dynamically present fused navigation images, bile duct opening location coordinates, and cannulation path guidance parameters in real time.

[0027] A method for an ERCP cannulation navigation system based on indocyanine green fluorescence imaging, wherein the ERCP cannulation navigation system based on indocyanine green fluorescence imaging requires the use of this method during use, and includes the following steps: S1: Using the ICG injection module, 30-60 minutes before the ERCP procedure, the patient is intravenously injected with a dose of indocyanine green contrast agent of 0.2-0.5 mg / kg body weight. After the contrast agent reaches the liver through blood circulation, it is specifically taken up by hepatocytes, excreted unchanged into the bile, and transported sequentially to the intrahepatic bile ducts and extrahepatic bile ducts. Finally, it accumulates at the opening of the bile duct in the duodenal papilla, completing the specific fluorescent labeling of the biliary system and forming the targeted biological target for systemic fluorescence imaging. S2: Connect the ICG injection module, ERCP cannulation module, operation control module, fluorescence endoscopy acquisition module, image signal processing module, and navigation display module through a dedicated interface. Turn on the system and switch to white light imaging mode by default. Adjust each module to normal working condition. Hold the acquisition main unit of the fluorescence endoscopy acquisition module and slowly insert its insertion part into the patient's body. Adjust the bending angle of the front end of the insertion part by operating the angle control knob of the operation control unit. Precisely position the fluorescence endoscopy acquisition module to the duodenal papilla area through the real-time white light image displayed by the navigation display module. S3: Fluorescence Mode Activation and Signal Excitation: By using the mode switching button on the operation control unit of the fluorescence endoscope acquisition module or the mode switching button on the human-computer interaction unit of the image signal processing module, the system is switched to fluorescence imaging mode via the mode switching unit of the operation control module. The emission intensity of the near-infrared light source is adjusted by the light source adjustment unit, so that the laser emission unit of the fluorescence endoscope acquisition module emits a near-infrared laser with a wavelength of 700-900nm. The laser penetrates the tip cap of the insertion part protection unit and irradiates the duodenal papilla region, exciting the indocyanine green enriched at the bile duct opening to generate a specific near-infrared fluorescence signal with a wavelength of about 800nm. S4: Image Acquisition and Fusion Processing: In the image sensing unit of the fluorescence endoscope acquisition module, the fluorescence image sensor synchronously acquires the original near-infrared fluorescence image of the nipple region after filtering out interference light through a near-infrared filter. The white light imaging component synchronously acquires the original white light image of the same region. The two original images are transmitted in real time to the signal receiving end of the signal transmission unit of the image signal processing module through the signal transmission cable encapsulated inside the insertion section. The algorithm processing unit of the image signal processing module first removes interference signals such as tissue scattering and equipment noise through a noise reduction algorithm, then enhances the contrast of the fluorescence signal through a fluorescence enhancement algorithm. Subsequently, the processed fluorescence image is accurately superimposed on the corresponding position of the white light image in a pseudo-color high-brightness form through an image fusion algorithm to generate a fused fluorescence navigation image. At the same time, the spatial coordinate calculation algorithm is used to locate the center position of the bile duct opening and extract the cannulation path guidance parameters. S5: Fluorescence-guided targeted cannulation: The image signal processing module transmits the fused fluorescence navigation image and cannulation path guidance parameters to the navigation display module in real time via the signal transmission unit display output terminal and the wireless communication unit. The physician can clearly identify the highlighted bile duct fluorescence channel through the display hardware unit of the navigation display module, and distinguish the bile duct opening from the pancreatic duct opening based on the difference in fluorescence imaging. The cannulation instrument of the ERCP cannulation module is sent in through the instrument access unit of the fluorescence endoscope acquisition module and extends out through the working channel outlet of the insertion part. Under the real-time guidance of the fused fluorescence navigation image, the cannulation instrument is slowly advanced so that the instrument is accurately inserted into the fluorescently marked common bile duct opening. If the surgical field is blurred, the water injection and air injection functions are activated through the auxiliary operation unit of the operation control module to clear the surgical field and ensure smooth cannulation operation. S6: Intubation Verification and Subsequent Operations: After the intubation instrument is inserted into the common bile duct, a brief X-ray fluoroscopy scan can be used to help confirm the precise position of the intubation instrument in the bile duct. After confirmation, the physician can flexibly switch between white light and fluorescence imaging modes through the mode switching unit of the operation control module according to the needs of the surgery, and complete subsequent ERCP-related operations such as sphincterotomy, stone removal, and angiography. The status of the bile duct area can be monitored in real time through the navigation display module throughout the operation.

[0028] The working principle of the ERCP cannulation navigation system and method based on indocyanine green fluorescence imaging provided by this invention is as follows: Preoperative fluorescent target preparation: A 52-year-old female patient with common bile duct stones was selected. Clinical assessment indicated moderate difficulty in routine cannulation, with no papillary anatomical variations. Forty minutes prior to ERCP, 0.3 mg / kg of indocyanine green contrast agent was injected intravenously into the forearm via the ICG injection module. The contrast agent reached the liver via blood circulation and was specifically taken up by hepatocytes, excreted unchanged into the bile, and sequentially transported to the intrahepatic and extrahepatic bile ducts. It ultimately accumulated at the bile duct opening at duodenal papilla 28, completing the specific fluorescent labeling of the biliary system and forming a clear bile duct fluorescent channel. System debugging and endoscopic positioning: The fluorescence endoscope acquisition module was wired to the signal receiver of the image signal processing module via a signal connection unit. The image signal processing module displayed... The output end and wireless communication unit establish connections with the fixed and portable display terminals of the navigation display module, respectively. The system is then powered on, defaulting to white light imaging mode. Each module and unit is debugged to normal operating condition, confirming that image transmission, mode switching, and light source adjustment functions are working correctly. The physician holds the main acquisition unit of the fluorescence endoscope acquisition module and slowly inserts its insertion part into the patient's body. The angle control knob of the operation control unit is used to adjust the bending angle of the insertion part's front end. Real-time white light images are observed through the fixed display terminal of the navigation display module. After approximately 5 minutes, the fluorescence endoscope acquisition module is precisely positioned in the duodenal papilla region, providing a clear surgical field. Water and air injection are not required. Fluorescence mode activation and signal excitation: The physician operates the fluorescence endoscope acquisition module... The control unit mode switching button seamlessly switches the system to fluorescence imaging mode via the mode switching unit of the operation control module. The light source intensity adjustment button adjusts the near-infrared light source to level two via the light source adjustment unit. The near-infrared laser emission window of the laser emission unit emits an 800nm ​​wavelength near-infrared laser. The laser penetrates the tip cap of the protective unit and precisely irradiates the duodenal papilla region, exciting the indocyanine green enriched at the bile duct opening to generate a specific 810nm wavelength near-infrared fluorescence signal. Image acquisition and fusion processing: In the image sensing unit of the fluorescence endoscopy acquisition module, the fluorescence image sensor simultaneously acquires the original near-infrared fluorescence image of the papilla region after filtering out interference light such as tissue scattering through a near-infrared filter. The white light imaging component simultaneously acquires the same region... The original white light image and the original white light image are transmitted in real time and without loss to the signal receiving end of the image signal processing module via the signal transmission cable inside the insertion unit. Driven by the hardware processing unit, the algorithm calculation unit first uses a noise reduction algorithm to remove interference signals such as equipment noise and tissue scattering, and then uses a fluorescence enhancement algorithm to improve the contrast of the fluorescence signal. Subsequently, the processed fluorescence image is precisely superimposed on the corresponding anatomical position of the white light image in a red pseudo-color highlight form through an image fusion algorithm to generate a fused fluorescence navigation image. At the same time, the spatial coordinate calculation algorithm accurately locates the center position of the bile duct opening and extracts the cannulation path guidance parameters. Targeted cannulation under fluorescence navigation: The image signal processing module combines the generated fused fluorescence navigation image with the cannulation path guidance parameters.The signal is simultaneously transmitted to a fixed display device and a portable display device via the signal transmission unit's display output and the wireless communication unit. The physician clearly identifies the highlighted fluorescent channels of the bile duct using the portable display device and, based on the difference in fluorescence imaging, clearly distinguishes the bile duct opening from the pancreatic duct opening, which lacks fluorescence imaging. The ERCP cannulation module's cannulation instruments, such as the guidewire, are inserted through the instrument access unit of the fluorescence endoscope acquisition module and slowly extend through the working channel outlet. Under the real-time guidance of the fused fluorescence navigation image, the guidewire tip is aligned with the center of the highlighted bile duct opening, and the guidewire is slowly advanced. The cannulation is accurately inserted into the common bile duct opening on the first attempt. The cannulation process takes approximately one minute, without touching the pancreatic duct opening, and the surgical field remains clear. Cannulation verification and subsequent operations: After the guidewire is inserted into the common bile duct, a brief X-ray fluoroscopy is used. The scan, lasting less than one minute, helped confirm the precise position of the intubation instruments within the common bile duct. Once the position was confirmed, the physician switched the system back to white light imaging mode via the mode switching unit of the control module. A papillary incision knife was then inserted through the instrument access unit to perform a small incision in the sphincter of Oddi, followed by the placement of a basket for stone retrieval. The stones in the common bile duct were successfully removed. Throughout the ERCP procedure, the status of the biliary region was monitored in real-time via the navigation display. The entire procedure was smooth. Postoperative condition: The patient's surgery was short, vital signs were stable during the procedure, and there were no significant discomforts. After returning to the ward, the patient experienced no abdominal pain, nausea, or vomiting, and no postoperative complications such as pancreatitis, bleeding, or perforation occurred. On the third postoperative day, liver function and serum amylase levels returned to normal, allowing for successful discharge.

[0029] Compared with related technologies, the ERCP cannulation navigation system and method based on indocyanine green fluorescence imaging provided by this invention have the following advantages: This invention integrates an ICG injection module, an ERCP cannulation module, an operation control module, a fluorescence endoscopy acquisition module, an image signal processing module, and a navigation display module. Each module has refined functional units and hardware units. It also includes a standardized usage method designed to fit the system hardware and the metabolic characteristics of indocyanine green. Utilizing the hepatobiliary-specific metabolic characteristics of indocyanine green, it provides a specific fluorescent target for the system. Combined with near-infrared fluorescence imaging technology, it achieves real-time visual navigation within the ERCP cannulation lumen, transforming traditional "blind" operation into "visual and precise operation." The system provides clear endoscopic landmarks, significantly improving the first-time success rate of cannulation, especially in cases with difficult cannulation such as papillary variations or peridiverticulum papillae. Furthermore, the system clearly distinguishes between the bile duct opening and the pancreatic duct opening through fluorescence contrast, minimizing mechanical stimulation of the pancreatic duct by the ERCP cannulation module and reducing the risk of accidental injection of contrast agent. This fundamentally lowers the incidence of postoperative pancreatitis. Indocyanine green is a routinely used clinical diagnostic drug, metabolized rapidly, and radiation-free. The clearly defined contrast agent injection parameters in the usage instructions ensure high safety with no additional clinical risks. Simultaneously, the visual navigation significantly reduces the need for X-rays. The use and duration of X-ray fluoroscopy significantly reduce the cumulative X-ray radiation exposure for both doctors and patients. All modules and units are integrated and detachably connected. The usage method is highly compatible with routine ERCP procedures. The instrument access unit can directly adapt to standard ERCP cannulation instruments without significantly altering existing ERCP procedures. It exhibits strong compatibility with existing ERCP equipment, and the clear and convenient usage steps make it easy for physicians to learn. The system hardware is compatible with clinical sterilization and operating room environments, facilitating widespread clinical application. Furthermore, the system supports both fixed and portable display devices, enabling wired and wireless dual communication. With dual control design and multi-parameter adjustable functions, system parameters can be flexibly adjusted based on different patients' fluorescence imaging effects, different operating table layouts, and different operational requirements, meeting diverse clinical needs for ERCP cannulation. The backup power interface enhances the safety of clinical use. The system's overall operation is responsive, effectively shortening surgical time, reducing repeated insertion attempts, minimizing patient discomfort during surgery, and reducing the manpower and time costs of clinical operations. Example

[0030] Please refer to the following: Figures 6-7 , Figure 6 This is a schematic diagram of a second embodiment of the ERCP cannulation navigation system based on indocyanine green fluorescence imaging provided by the present invention; Figure 7This invention provides a schematic diagram of an image sensing unit. Based on the ERCP cannulation navigation system and method based on indocyanine green fluorescence imaging provided in the first embodiment of this application, the second embodiment of this application proposes another ERCP cannulation navigation system based on indocyanine green fluorescence imaging. The second embodiment is merely a preferred embodiment of the first embodiment, and the implementation of the second embodiment will not affect the separate implementation of the first embodiment.

[0031] Specifically, the difference between the ERCP cannulation navigation system and method based on indocyanine green fluorescence imaging provided in the second embodiment of this application is that the laser emitting unit includes a near-infrared laser source emitting window and a micro electric adjustment component. The micro electric adjustment component is rigidly connected to the near-infrared laser source emitting window and is encapsulated in the front end of the endoscope, which can realize stepless adjustment of the laser emission angle within the range of ±15°. The adjustment signal is transmitted through a dedicated channel and can be controlled by the operation control unit or the image signal processing module.

[0032] The image sensing unit includes a fluorescence image sensor, a white light imaging component, and an optical axis calibration module. The optical axis calibration module is integrated between the fluorescence image sensor and the white light imaging component and has a built-in micro-displacement adjustment mechanism, which can realize micron-level position compensation in the lateral and longitudinal directions. Physicians can also manually fine-tune the system by operating the control unit to ensure that the bright bile duct fluorescence channel and the anatomical structure of the duodenal papilla are accurately superimposed in the fused navigation image, providing unbiased visual guidance for cannulation.

[0033] Compared with related technologies, the ERCP cannulation navigation system based on indocyanine green fluorescence imaging provided by this invention has the following advantages: When the navigation display module detects weak fluorescence signals or incomplete target display, an adjustment command can be issued through the operating interface. This command, via a miniature electric adjustment component, rotates the near-infrared laser source emission window around the endoscope's front axis, allowing the near-infrared laser to precisely irradiate the ICG-rich bile duct opening region. This fully excites the specific fluorescence signal, providing a stable and clear fluorescence imaging source for the image sensing unit. The system continuously monitors the spatial offset between the images acquired by the fluorescence image sensor and the white light imaging component. When the offset exceeds a threshold, the algorithm unit of the image signal processing module generates a calibration command, driving the optical axis calibration module to adjust the relative positions of the two imaging components, automatically aligning the optical axes. Physicians can also manually fine-tune the image through the control unit to ensure precise superposition of the bile duct fluorescence channel and the duodenal papilla anatomical structure in the fused navigation image. To provide precise visual guidance for intubation, this design addresses the issue of incomplete laser excitation in cases with occult or variant papillae by flexibly adjusting the laser emission angle, expanding the system's applicability to difficult intubation cases. The optical axis calibration module compensates for image misalignment caused by endoscope curvature and changes in body position, preventing the fluorescence target from shifting from the white light anatomical structure, reducing physician visual judgment errors, improving intubation accuracy, and lowering the risk of pancreatic duct injury. Moreover, the structural optimization is limited to the laser emission unit and image sensing unit, without changing the connection methods and operating logic with other units of the fluorescence endoscope acquisition module and other modules of the system. Clinical switching costs are low, and adjustment and calibration functions can be achieved through the original operating interface. The automatic calibration mode reduces manual intervention by physicians, adapts to the rhythm of clinical ERCP operations, and improves the continuity and efficiency of surgery.

[0034] The above description is merely an embodiment of the present invention and does not limit the patent scope of the present invention. Any equivalent structural or procedural transformations made based on the content of the present invention specification and drawings, or direct or indirect applications in other related technical fields, are similarly included within the patent protection scope of the present invention.

Claims

1. An ERCP cannulation navigation system based on indocyanine green fluorescence imaging, characterized in that, include: The system includes an ICG injection module, a fluorescence endoscope acquisition module, an ERCP cannulation module, an operation control module, an image signal processing module, and a navigation display module. The ICG injection module is a preoperative fluorescent target preparation unit used to inject indocyanine green contrast agent into the patient intravenously. After being taken up by hepatocytes, the contrast agent is enriched in the bile at the opening of the duodenal papilla, forming a targeted biological target for systematic fluorescence imaging. The fluorescence endoscope acquisition module is the core hardware for image and signal acquisition of the system. It is used to acquire ordinary white light images and near-infrared fluorescence images of the duodenal region, and at the same time emits a near-infrared laser to excite indocyanine green to generate a specific near-infrared fluorescence signal. The ERCP cannulation module includes conventional ERCP cannulation instruments such as guidewires, duodenal papilla incision knives, and contrast tubes, which are inserted via a fluorescence endoscope acquisition module to complete the cannulation operation. The operation control module is the core of the system's command input and equipment control. It is linked with the fluorescence endoscope acquisition module and the image signal processing module to control the switching of imaging modes, the adjustment of near-infrared light source intensity, and the auxiliary control of water and gas injection in conjunction with ERCP cannulation operations. The image signal processing module is the core hardware for data analysis and processing of the system. It is used to receive the raw images and signals transmitted by the fluorescence endoscope acquisition module, process them by the algorithm to generate real-time fluorescence navigation images, and at the same time complete the spatial positioning of the bile duct opening center and the extraction of cannulation path guidance parameters. The navigation display module is the core hardware for image and parameter output of the system. It is used to output fused fluorescence navigation images and cannulation path guidance parameters in real time, and dynamically present the highlighted bile duct openings and surrounding anatomical structures.

2. The ERCP cannulation navigation system based on indocyanine green fluorescence imaging according to claim 1, characterized in that, The operation control module includes a mode switching unit, a light source adjustment unit, and an auxiliary operation unit. The mode switching unit supports real-time seamless switching between fluorescence imaging mode and white light imaging mode. The light source adjustment unit enables multi-level adjustable intensity of near-infrared light source. The auxiliary operation unit enables quantitative and continuous dual-mode adjustable control of water injection and gas injection.

3. The ERCP cannulation navigation system based on indocyanine green fluorescence imaging according to claim 1, characterized in that, The fluorescence endoscope acquisition module includes an acquisition main unit, a laser emission unit, an image sensing unit, a protection unit, an operation control unit, an instrument access unit, a signal connection unit, and a media connection unit. The acquisition main unit is a side-viewing duodenoscope modified with integrated near-infrared fluorescence function, including an insertion part, an operation part, and a connection part. The laser emission unit is a near-infrared laser source emission window, integrated at the front end of the insertion part of the acquisition main unit. The image sensing units are all integrated at the front end of the insertion part of the acquisition main unit, and the insertion part of the acquisition main unit is encapsulated with signal transmission cables and auxiliary channel pipelines.

4. The ERCP cannulation navigation system based on indocyanine green fluorescence imaging according to claim 3, characterized in that, The protective unit is a cap made of transparent medical polymer material, located at the front end of the insertion part of the acquisition main unit. It can transmit near-infrared laser and fluorescence signals and is adapted to the bending angle adjustment of the insertion part. The insertion part also integrates an optical fiber transmission line, which is connected to the near-infrared laser source emission window of the laser emission unit to achieve stable transmission and emission of near-infrared laser. The operation control unit is integrated into the operation part of the acquisition main unit, including an angle control knob, a mode switching button, and a light source intensity adjustment button. The instrument access unit is a biopsy channel interface, located in the operation part of the acquisition main unit, and is compatible with various intubation instruments of the ERCP intubation module. The signal connection unit is a general signal interface, and the medium connection unit is an auxiliary channel interface, both located in the connection part of the acquisition main unit, respectively realizing the signal connection with the image signal processing module and the medium connection with external water injection and gas injection equipment.

5. The ERCP cannulation navigation system based on indocyanine green fluorescence imaging according to claim 1, characterized in that, The image signal processing module includes a hardware processing unit, an algorithm calculation unit, a human-computer interaction unit, a signal transmission unit, and a wireless communication unit.

6. The ERCP cannulation navigation system based on indocyanine green fluorescence imaging according to claim 5, characterized in that, The hardware processing unit is the core computing hardware. The algorithm computing unit has built-in noise reduction algorithm, fluorescence enhancement algorithm, image fusion algorithm, and spatial coordinate calculation algorithm. It can eliminate interference signals such as tissue scattering and equipment noise, improve the contrast of fluorescence signals, and accurately superimpose the fluorescence image on the corresponding position of the white light image in pseudo-color high brightness form to achieve image fusion display of fluorescence and white light modes. The human-computer interaction unit is an operation panel that integrates mode switching keys, light source adjustment keys, image enhancement keys, and water injection and gas injection control keys. It forms a dual control with the operation control unit of the fluorescence endoscope acquisition module, which is adapted to clinical operation habits. The signal transmission unit is equipped with a signal receiving end, a power interface, a display output end, and a backup power interface to achieve seamless switching between signal reception, equipment power supply, and sudden power failure. The wireless communication unit is used to achieve wireless signal transmission with the portable display terminal of the navigation display module.

7. The ERCP cannulation navigation system based on indocyanine green fluorescence imaging according to claim 1, characterized in that, The navigation display module includes a display hardware unit and an image output unit. The display hardware unit is a high-definition medical display screen, which includes a fixed display device and a portable display device. It is connected to the signal transmission unit of the image signal processing module through wired and wireless dual communication methods. The image output unit supports image magnification, freeze, and playback functions, and can dynamically present fused navigation images, bile duct opening location coordinates, and cannulation path guidance parameters in real time.

8. The ERCP cannulation navigation system based on indocyanine green fluorescence imaging according to claim 3, characterized in that, The laser emitting unit includes a near-infrared laser source emitting window and a micro-electric adjustment component. The micro-electric adjustment component is rigidly connected to the near-infrared laser source emitting window and is encapsulated in the front end of the endoscope, enabling stepless adjustment of the laser emission angle within a range of ±15°.

9. The ERCP cannulation navigation system based on indocyanine green fluorescence imaging according to claim 3, characterized in that, The image sensing unit includes a fluorescence image sensor, a white light imaging component, and an optical axis calibration module. The optical axis calibration module is integrated between the fluorescence image sensor and the white light imaging component and has a built-in micro-displacement adjustment mechanism, which can achieve micron-level position compensation in the lateral and longitudinal directions.

10. A method for an ERCP cannulation navigation system based on indocyanine green fluorescence imaging, characterized in that, The system includes an ERCP cannulation navigation system based on indocyanine green fluorescence imaging as described in any one of claims 1-9, wherein the ERCP cannulation navigation system based on indocyanine green fluorescence imaging requires a method for using the ERCP cannulation navigation system based on indocyanine green fluorescence imaging, comprising the following steps: S1: Using the ICG injection module, 30-60 minutes before the ERCP procedure, the patient is intravenously injected with a dose of indocyanine green contrast agent of 0.2-0.5 mg / kg body weight. After the contrast agent reaches the liver through blood circulation, it is specifically taken up by hepatocytes, excreted unchanged into the bile, and transported sequentially to the intrahepatic bile ducts and extrahepatic bile ducts. Finally, it accumulates at the opening of the bile duct in the duodenal papilla, completing the specific fluorescent labeling of the biliary system and forming the targeted biological target for systemic fluorescence imaging. S2: Connect the ICG injection module, ERCP cannulation module, operation control module, fluorescence endoscopy acquisition module, image signal processing module, and navigation display module through a dedicated interface. Turn on the system and switch to white light imaging mode by default. Adjust each module to normal working condition. Hold the acquisition main unit of the fluorescence endoscopy acquisition module and slowly insert its insertion part into the patient's body. Adjust the bending angle of the front end of the insertion part by operating the angle control knob of the operation control unit. Precisely position the fluorescence endoscopy acquisition module to the duodenal papilla area through the real-time white light image displayed by the navigation display module. S3: Fluorescence Mode Activation and Signal Excitation: By using the mode switching button on the operation control unit of the fluorescence endoscope acquisition module or the mode switching button on the human-computer interaction unit of the image signal processing module, the system is switched to fluorescence imaging mode via the mode switching unit of the operation control module. The emission intensity of the near-infrared light source is adjusted by the light source adjustment unit, so that the laser emission unit of the fluorescence endoscope acquisition module emits a near-infrared laser with a wavelength of 700-900nm. The laser penetrates the tip cap of the insertion part protection unit and irradiates the duodenal papilla region, exciting the indocyanine green enriched at the bile duct opening to generate a specific near-infrared fluorescence signal with a wavelength of about 800nm. S4: Image Acquisition and Fusion Processing: In the image sensing unit of the fluorescence endoscope acquisition module, the fluorescence image sensor synchronously acquires the original near-infrared fluorescence image of the nipple region after filtering out interference light through a near-infrared filter. The white light imaging component synchronously acquires the original white light image of the same region. The two original images are transmitted in real time to the signal receiving end of the signal transmission unit of the image signal processing module through the signal transmission cable encapsulated inside the insertion section. The algorithm processing unit of the image signal processing module first removes interference signals such as tissue scattering and equipment noise through a noise reduction algorithm, then enhances the contrast of the fluorescence signal through a fluorescence enhancement algorithm. Subsequently, the processed fluorescence image is accurately superimposed on the corresponding position of the white light image in a pseudo-color high-brightness form through an image fusion algorithm to generate a fused fluorescence navigation image. At the same time, the spatial coordinate calculation algorithm is used to locate the center position of the bile duct opening and extract the cannulation path guidance parameters. S5: Fluorescence-guided targeted cannulation: The image signal processing module transmits the fused fluorescence navigation image and cannulation path guidance parameters to the navigation display module in real time via the signal transmission unit display output terminal and the wireless communication unit. The physician can clearly identify the highlighted bile duct fluorescence channel through the display hardware unit of the navigation display module, and distinguish the bile duct opening from the pancreatic duct opening based on the difference in fluorescence imaging. The cannulation instrument of the ERCP cannulation module is sent in through the instrument access unit of the fluorescence endoscope acquisition module and extends out through the working channel outlet of the insertion part. Under the real-time guidance of the fused fluorescence navigation image, the cannulation instrument is slowly advanced so that the instrument is accurately inserted into the fluorescently marked common bile duct opening. If the surgical field is blurred, the water injection and air injection functions are activated through the auxiliary operation unit of the operation control module to clear the surgical field and ensure smooth cannulation operation. S6: Intubation Verification and Subsequent Operations: After the intubation instrument is inserted into the common bile duct, a brief X-ray fluoroscopy scan can be used to help confirm the precise position of the intubation instrument in the bile duct. After confirmation, the physician can flexibly switch between white light and fluorescence imaging modes through the mode switching unit of the operation control module according to the needs of the surgery, and complete subsequent ERCP-related operations such as sphincterotomy, stone removal, and angiography. The status of the bile duct area can be monitored in real time through the navigation display module throughout the operation.

Images