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CN-122005092-A - ERCP cannula navigation system and method based on indocyanine green fluorescence imaging

CN122005092ACN 122005092 ACN122005092 ACN 122005092ACN-122005092-A

Abstract

The invention provides an ERCP cannula 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, wherein the ICG injection module is a pre-operation fluorescence target preparation unit and is used for intravenous injection of indocyanine green contrast agent to a patient, so that the contrast agent is enriched at a biliary tract opening of a duodenal papilla along with bile after being ingested by liver cells, and a targeted biological target of the system fluorescence imaging is formed. The ERCP intubation navigation system and the ERCP intubation navigation method based on indocyanine green fluorescence imaging, provided by the invention, meet the diversified clinical operation requirements of ERCP intubation, the design of the standby power interface improves the safety of clinical use of the system, the whole operation response of the system is rapid, the operation time can be effectively shortened, the repeated trial insertion times are reduced, the discomfort in the operation of patients is reduced, and the labor and time cost of clinical operation are reduced.

Inventors

  • NIE FAXIAN
  • LI JIE

Assignees

  • 攀钢集团总医院

Dates

Publication Date
20260512
Application Date
20260326

Claims (10)

  1. 1. The ERCP intubation navigation system based on indocyanine green fluorescence imaging is characterized by comprising 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 pre-operation fluorescent target preparation unit and is used for intravenous injection of indocyanine green contrast agent into a patient, so that the contrast agent is enriched at the opening of the biliary tract of the duodenal papilla along with bile after being taken in by liver cells, and a targeted biological target of system fluorescent imaging is formed; The fluorescence endoscope acquisition module is image and signal acquisition core hardware of the system and is used for acquiring a common white light image and a near infrared fluorescence image of a duodenal region and simultaneously transmitting near infrared laser to excite indocyanine green to generate a specific near infrared fluorescence signal; the ERCP intubation module comprises a guide wire, a duodenal papilla incision knife, a contrast tube and other conventional ERCP intubation instruments, and the ERCP intubation instruments are fed through the fluorescence endoscope acquisition module to complete intubation operation; the operation control module is a system instruction input and equipment control core, is linked with the fluorescence endoscope acquisition module and the image signal processing module, and is used for controlling imaging mode switching, near infrared light source intensity adjustment and water injection and gas injection auxiliary control matched with ERCP intubation operation; The image signal processing module is data analysis and processing core hardware of the system and is used for receiving the original image and the signal transmitted by the fluorescence endoscope acquisition module, generating a real-time fluorescence navigation image after algorithm processing, and simultaneously completing biliary tract opening center position spatial positioning and cannula path guiding parameter extraction; The navigation display module is image and parameter output core hardware of the system and is used for outputting fused fluorescence navigation images and cannula path guiding parameters in real time and dynamically presenting a biliary tract opening and surrounding anatomical structures with highlight marks.
  2. 2. The ERCP cannula navigation system based on indocyanine green fluorescence imaging according to claim 1, wherein the operation control module comprises a mode switching unit, a light source adjusting unit and an auxiliary operation unit, the mode switching unit is used for supporting real-time seamless switching between a fluorescence imaging mode and a white light imaging mode, the light source adjusting unit is used for realizing multistage adjustment of the intensity of a near infrared light source, and the auxiliary operation unit is used for realizing quantitative and continuous double-mode adjustment of water injection and gas injection control.
  3. 3. The ERCP cannula navigation system based on indocyanine green fluorescence imaging according to claim 1, wherein the fluorescence endoscope acquisition module comprises an acquisition main body 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 medium connection unit, wherein the acquisition main body unit is a side-looking duodenoscope which is subjected to near infrared fluorescence function integrated reconstruction and comprises an insertion part, an operation part and a connection part, the laser emission unit is a near infrared laser light source emission window and is integrated at the front end of the insertion part of the acquisition main body unit, and the image sensing units are integrated at the front end of the insertion part of the acquisition main body unit and internally package a signal transmission cable and an auxiliary channel pipeline.
  4. 4. The ERCP cannula navigation system based on indocyanine green fluorescence imaging according to claim 3, wherein the protection unit is a front end cap made of transparent medical polymer material, is arranged at the front end of an insertion part of the acquisition main body unit, can transmit near infrared laser and fluorescent signals and is adaptive to the bending angle adjustment of the insertion part, an optical cable transmission line is integrated in the insertion part and is connected with a near infrared laser light source emission window of the laser emission unit, so that stable transmission and emission of near infrared laser are realized, the operation control unit is integrated in an operation part of the acquisition main body unit, comprises an angle control knob, a mode switching key and a light source intensity adjusting key, the instrument access unit is a biopsy duct interface, is arranged at the operation part of the acquisition main body unit, is adaptive to various cannula instruments of the ERCP cannula module, the signal connection unit is a universal signal interface, the medium connection unit is an auxiliary channel interface and is arranged at the connection part of the acquisition main body unit, and signal connection with the image signal processing module and medium connection with external water injection and gas injection equipment are realized respectively.
  5. 5. The ERCP cannula navigation system based on indocyanine green fluorescence imaging of claim 1, wherein the image signal processing module comprises a hardware processing unit, an algorithm operation unit, a man-machine interaction unit, a signal transmission unit and a wireless communication unit.
  6. 6. The ERCP cannula navigation system based on indocyanine green fluorescence imaging according to claim 5, wherein the hardware processing unit is core operation hardware, the algorithm operation unit is internally provided with a noise reduction algorithm, a fluorescence enhancement algorithm, an image fusion algorithm and a space coordinate calculation algorithm, interference signals such as tissue scattering, equipment noise and the like can be removed, fluorescence signal contrast is improved, a fluorescence image is precisely overlapped at a position corresponding to a white light image in a pseudo-color highlighting mode, image fusion display of fluorescence and white light modes is achieved, the man-machine interaction unit is an operation panel, an integrated mode switching key, a light source adjusting key, an image enhancement key and a water injection and gas injection control key form dual control with an operation control unit key of a fluorescence endoscope acquisition module, clinical operation habit is adapted, the signal transmission unit is provided with a signal receiving end, a power interface, a display output end and a standby power interface, signal receiving, equipment power supply and burst power failure seamless switching are achieved, and the wireless communication unit is used for achieving wireless signal transmission with a portable display terminal of a navigation display module.
  7. 7. The ERCP cannula navigation system based on indocyanine green fluorescence imaging according to claim 1, wherein the navigation display module comprises a display hardware unit and an image output unit, the display hardware unit is a high-definition medical display screen, comprises fixed display equipment and portable display equipment, is connected with a signal transmission unit of the image signal processing module in a wired and wireless dual-communication mode, and supports the functions of picture amplification, freezing and playback, and can dynamically present fusion navigation images, biliary tract opening positioning coordinates and cannula path guiding parameters in real time.
  8. 8. The ERCP cannula navigation system based on indocyanine green fluorescence imaging according to claim 3, wherein the laser emission unit comprises a near infrared laser light source emission window and a miniature electric adjustment assembly, the miniature electric adjustment assembly is rigidly connected with the near infrared laser light source emission window, is packaged at the front end of an endoscope, and can realize stepless adjustment of the laser emission angle within a range of +/-15 degrees.
  9. 9. The ERCP cannula navigation system based on indocyanine green fluorescence imaging of claim 3, wherein the image sensing unit comprises 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 a micro-displacement adjusting mechanism is arranged in the optical axis calibration module, so that the lateral and longitudinal micrometer-level position compensation can be realized.
  10. 10. A method of an ERCP cannula navigation system based on indocyanine green fluorescence imaging, comprising an ERCP cannula navigation system based on indocyanine green fluorescence imaging according to any one of claims 1 to 9, wherein the method of using the ERCP cannula navigation system based on indocyanine green fluorescence imaging is needed when the ERCP cannula navigation system based on indocyanine green fluorescence imaging is used, comprising the following steps: S1, intravenous injection of indocyanine green contrast agent with the dosage of 0.2-0.5mg/kg body weight into a patient 30-60 minutes before ERCP operation is performed through an ICG injection module, and the contrast agent is specifically ingested through liver cells after reaching the liver along with blood circulation, is discharged into bile in an original shape and sequentially transported to an intrahepatic bile duct and an extrahepatic bile duct, is finally enriched at an opening of the duodenal papilla biliary tract, and completes specific fluorescent marking of a biliary tract system to form a targeted biological target of system fluorescent imaging; S2, electrically connecting an ICG injection module, an ERCP intubation module, an operation control module, a fluorescence endoscope acquisition module, an image signal processing module and a navigation display module through special interfaces, starting a system, switching to a white light imaging mode by default, debugging each module to a normal working state, holding an acquisition main body unit of the fluorescence endoscope acquisition module by a doctor, slowly placing an insertion part of the acquisition main body unit into a patient, controlling an angle control knob of the operation control unit to adjust the bending angle of the front end of the insertion part, and accurately positioning the fluorescence endoscope acquisition module to a duodenal papilla region through a white light image displayed in real time by the navigation display module; S3, starting a fluorescence mode and exciting a signal, namely switching the system to a fluorescence imaging mode through a mode switching key of an operation control unit of a fluorescence endoscope acquisition module or a mode switching key of a man-machine interaction unit of an image signal processing module, adjusting the emission intensity of a near infrared light source through a light source adjusting unit to enable a laser emission unit of the fluorescence endoscope acquisition module to emit near infrared laser with the wavelength of 700-900nm, enabling the laser to penetrate through a front end cap of an insertion part protection unit to irradiate a duodenal papilla area, and exciting indocyanine green enriched at a biliary tract opening to generate a specific near infrared fluorescence signal with the wavelength of about 800 nm; S4, image acquisition and fusion processing, namely, in an image sensing unit of a fluorescence endoscope acquisition module, a fluorescence image sensor synchronously acquires near infrared fluorescence original images of nipple areas after filtering interference light through a near infrared filter, a white light imaging component synchronously acquires white light original images of the same areas, and the two original images are transmitted to a signal receiving end of a signal transmission unit of an image signal processing module in real time through a signal transmission cable packaged in an insertion part; S5, targeting intubation under fluorescence navigation, namely, an image signal processing module transmits a fused fluorescence navigation image and intubation path guiding parameters to a navigation display module in real time through a display output end of a signal transmission unit and a wireless communication unit, a doctor clearly identifies a bile duct fluorescence channel with a highlight mark through a display hardware unit of the navigation display module, distinguishes a bile duct opening and a pancreatic duct opening according to fluorescence development difference, an intubation instrument of an ERCP intubation module is fed through an instrument access unit of a fluorescence endoscope acquisition module and extends out through an outlet of an insertion part working channel, the intubation instrument is slowly pushed under the real-time guidance of the fused fluorescence navigation image, the instrument is accurately inserted into a bile duct opening with the fluorescent mark, if the visual field of an operation area is fuzzy, a water injection and gas injection function is started through an auxiliary operation unit of an operation control module, the visual field of the operation area is cleaned, and the intubation operation is ensured smooth; And S6, performing intubation verification and subsequent operation, namely performing short-term scanning by utilizing X-ray perspective after the intubation instrument is placed into the common bile duct, assisting in confirming the accurate position of the intubation instrument in the biliary tract, flexibly switching a white light imaging mode and a fluorescent imaging mode by a mode switching unit of an operation control module according to operation requirements after confirmation, completing subsequent ERCP related operations such as papillary sphincter cutting, lithotomy, radiography and the like, and monitoring the state body of the biliary tract region in real time by a navigation display module in the whole operation process.

Description

ERCP cannula navigation system and method based on indocyanine green fluorescence imaging Technical Field The invention relates to the technical fields of medical instruments and clinical medicine, in particular to an ERCP cannula navigation system and method based on indocyanine green fluorescence imaging. Background ERCP is a core minimally invasive technology for diagnosing and treating biliary pancreatic diseases, the key primary step of successful operation is selective deep intubation of bile duct or pancreatic duct, no special visual navigation system is used for the operation of the conventional ERCP intubation at present, the heuristic intubation is mainly dependent on the personal clinical experience and X-ray perspective feedback of doctors, the pipeline anatomical structure in the duodenal papilla cannot be observed in real time, the intubation failure rate is high for difficult cases such as papilla variation, diverticulum papilla and the like, and meanwhile, the intubation instrument is repeatedly and unintentionally inserted into the pancreatic duct and contrast agent is injected, so that the clinical safety of ERCP operation is seriously restricted, X-ray perspective is frequently used in the whole operation process, the accumulated radiation damage of X-rays is caused to both doctors and patients, long-term health risks exist, the operation time is greatly prolonged by repeated trial insertion, discomfort in the operation of patients is increased, and meanwhile, the manpower and time cost of clinical operation is increased. Indocyanine green is used as a clinical routine liver function diagnosis medicament, has the characteristics of specific uptake of liver cells, discharge of bile in an original shape, no participation in liver and intestine circulation, half-life of only 3-4 minutes, quick metabolism and no residue, and can generate a stable near infrared fluorescence signal with a wavelength of about 800nm under the excitation of near infrared light with a wavelength of 700-900nm, and the near infrared fluorescence imaging technology is mature applied to surgical fluorescence laparoscopic surgery. The conventional ERCP intubation technology has a plurality of remarkable defects in the prior art, the blindness of the intubation process is high, an operating doctor mainly depends on personal clinical experience and X-ray perspective feedback to carry out trial intubation, a pipeline anatomical structure in the duodenal papilla cannot be observed in real time, the failure rate of intubation is high for difficult cases such as papilla variation, diverticulum and the like, the postoperative complication risk is high, the repeated unintentional insertion of an intubation instrument into a pancreatic duct and injection of contrast agent are the most important factors for inducing postoperative pancreatitis, the clinical safety of ERCP operation is severely restricted, the doctor-patient radiation exposure problem is that X-ray perspective is frequently used in the whole operation process, the doctor and a patient are subjected to X-ray accumulated radiation damage, long-term health risk exists, the operation efficiency is low, the repeated trial insertion can prolong the operation time, discomfort in the operation of the patient is increased, and meanwhile, the manpower and time cost of clinical operation is increased. Therefore, it is necessary to provide an ERCP cannula navigation system and method based on indocyanine green fluorescence imaging to solve the above technical problems. Disclosure of Invention The invention provides an ERCP cannula navigation system and method based on indocyanine green fluorescence imaging, which solve the problems of high blindness, high postoperative pancreatitis risk, doctor-patient radiation exposure and low operation efficiency of the traditional ERCP cannula. In order to solve the technical problems, the ERCP cannula navigation system and method based on indocyanine green fluorescence imaging provided by the invention comprise an ICG injection module, a fluorescence endoscope acquisition module, an ERCP cannula module, an operation control module, an image signal processing module and a navigation display module; the ICG injection module is a pre-operation fluorescent target preparation unit and is used for intravenous injection of indocyanine green contrast agent into a patient, so that the contrast agent is enriched at the opening of the biliary tract of the duodenal papilla along with bile after being taken in by liver cells, and a targeted biological target of system fluorescent imaging is formed; The fluorescence endoscope acquisition module is image and signal acquisition core hardware of the system and is used for acquiring a common white light image and a near infrared fluorescence image of a duodenal region and simultaneously transmitting near infrared laser to excite indocyanine green to generate a specific near infrared fluorescence signal; th