Multifunctional hysteroscope flexible lens

Abstract

The invention discloses a multifunctional soft hysteroscope which comprises an optical imaging system, a flexible hysteroscope body and biopsy forceps integrated in the flexible hysteroscope body. The optical imaging system comprises a lens end and a transmission line, and the lens end is integrated with a high-resolution camera shooting sensor and a light source system. Through the combined design of the optical amplification system, the small-diameter imaging optical fiber and the image sensor, on the premise that the diameter of the imaging optical fiber is smaller than the size of the image sensor, the imaging effect is improved; images can still be magnified through the optical system, the problem that the outer diameter of an insertion tube of an existing electronic hysteroscope is too large is solved, operation flexibility is guaranteed, and the fiber endoscope has the slender advantage of a fiber mirror and the high-definition imaging advantage of an electronic mirror; meanwhile, the flexible endoscope body is made of high-performance materials such as silica gel or polyurethane, 360-degree accurate bending can be achieved in cooperation with an external control mechanism, the flexible endoscope body can be matched with complex anatomical structures in the uterine cavity, the fallopian tube and the abdominal cavity, and the operation convenience of a doctor is improved.

Description

Technical Field

[0001] This invention relates to the field of flexible hysteroscopy, and more particularly to a multifunctional flexible hysteroscopy. Background Technology

[0002] In the current field of gynecology, flexible hysteroscopy has become an important medical instrument for the diagnosis and treatment of intrauterine diseases. Existing flexible hysteroscopes are typically made of special flexible materials, with a 360° flexible body, allowing doctors to easily enter the uterine cavity at different angles to comprehensively observe the health of the endometrium, cervix, and fallopian tube openings. Simultaneously, equipped with a high-definition digital imaging system and a miniature working channel, it can assist in the diagnosis of lesions such as endometrial hyperplasia and polyps through real-time clear imaging, and can also perform intrauterine tissue sampling, puncture biopsy, or minor interventional treatments through the working channel. It plays an important role in the diagnosis and treatment of infertility, endometriosis, and other diseases. Compared to traditional rigid hysteroscopy, it significantly improves the diagnostic rate of fallopian tube diseases and reduces patient discomfort and postoperative recovery time.

[0003] However, existing flexible hysteroscopes still have significant technical limitations: First, the limited length of the flexible endoscope prevents it from entering the abdominal cavity through the fallopian tubes, limiting its coverage to the cervix, uterine cavity, and proximal fallopian tubes. This prevents simultaneous exploration of the pelvic and abdominal cavities, requiring additional equipment such as laparoscopy for definitive diagnosis of pelvic and abdominal lesions. Second, there is a lack of specialized detection capabilities for abnormal blood vessels; current imaging systems cannot accurately identify abnormal blood vessels in lesion areas, limiting the early diagnosis rate of diseases such as malignant tumors. Third, pelvic and abdominal exploration relies on laparoscopic surgery, which traditionally requires general anesthesia, increasing anesthetic risks and surgical trauma, as well as treatment costs and postoperative recovery time. Fourth, some electronic hysteroscopes require larger insertion tube diameters due to limitations in the size of the image sensor at the lens end, affecting operational flexibility and patient comfort. These shortcomings make it difficult for existing flexible hysteroscopes to achieve integrated diagnosis of the cervix, uterus, fallopian tubes, ovaries, and pelvic and abdominal cavities, failing to meet the comprehensive assessment needs of complex gynecological diseases. Summary of the Invention

[0004] In order to overcome the shortcomings of the prior art, one of the objectives of this invention is to provide a multifunctional flexible hysteroscope.

[0005] One of the objectives of this invention is achieved through the following technical solution: A multifunctional flexible hysteroscope includes an optical imaging system, a flexible endoscope body, and biopsy forceps integrated within the flexible endoscope body; The optical imaging system includes a lens end and a transmission line. The lens end integrates a high-resolution camera sensor and a light source system. The light source system is used to provide illumination for the uterine cavity and abdominal cavity to obtain a clear field of view. One end of the transmission line is connected to the lens end, and the other end is used to connect to an external display device to transmit the digital video signal collected by the camera sensor to the external display device in real time. The flexible endoscope body is made of a material with high flexibility and high flexibility. Its length is configured to be able to enter the abdominal cavity through the fallopian tube. The flexible endoscope body is equipped with an external operating mechanism, which is used to control the bending angle and direction of the flexible endoscope body. The biopsy forceps are integrated into the working channel inside the flexible endoscope. The biopsy forceps are equipped with an external operating mechanism, which is used to control the opening, closing and rotation of the biopsy forceps to complete tissue sampling in the uterine cavity, fallopian tubes and abdominal cavity under the assistance of real-time imaging.

[0006] As a further improvement to the above technical solution: The optical imaging system includes a green light source, which is used to detect abnormal blood vessels in the uterine cavity and abdominal cavity to improve the diagnostic rate of malignant tumors.

[0007] The flexible mirror body is made of silicone or polyurethane, and the material can maintain structural stability when subjected to bending and twisting operations.

[0008] The biopsy forceps have a head made of medical-grade stainless steel with a smooth surface. The outer spring tube of the biopsy forceps has a plastic-coated structure to avoid damaging the working channel of the flexible endoscope. The biopsy forceps have a rigid four-bar structure with a gap between the forceps head and the cup mouth of less than 0.03 mm. All connecting parts of the biopsy forceps are fixed by laser welding.

[0009] The optical imaging system further includes an optical magnification system, which is disposed between the camera sensor and the imaging fiber. The end of the imaging fiber is located at the object plane of the optical magnification system, and the camera sensor is located at the image plane of the optical magnification system. The diameter of the imaging fiber is smaller than the size of the camera sensor.

[0010] The external control mechanism is a joystick or control handle, which can drive the flexible endoscope to bend freely in 360° to adapt to the observation and operation needs of different angles in the uterine cavity, fallopian tubes and abdominal cavity.

[0011] The high-resolution camera sensor of the optical imaging system is a high-performance CCD, and the optical imaging system is equipped with an electronic aperture. The electronic aperture is used to adjust the light intensity in real time according to the light environment in the uterine cavity and abdominal cavity to ensure the stability of the video signal image quality.

[0012] The flexible endoscope body includes a curved section, an insertion tube, an operating section, a light-guiding hose, and a light-guiding plug rod connected in sequence. The front end of the curved section is a tip containing the lens end, and the tip also has a forceps channel communicating with the working channel and a nozzle for water and air injection. The operating section integrates some components of the external operating mechanism and some components of the external operating mechanism. The operating section is equipped with a knob, a remote control button, a suction seat, a water and air seat, and a forceps seat. The knob is used to adjust the direction of the curved section, the remote control button is used to realize image freezing and imaging mode switching functions, the suction seat is used to connect the suction device, the water and air seat is used to connect the water and air injection device, and the forceps seat communicates with the working channel and is used to assist in the assembly and maintenance of the biopsy forceps.

[0013] 1. This invention increases the bendable length of the flexible endoscope, enabling it to smoothly pass through the fallopian tubes and enter the abdominal cavity. This breaks through the limitation of existing flexible hysteroscopes that can only explore the uterine cavity and the proximal end of the fallopian tubes. It can simultaneously complete the exploration of multiple sites in the deep cervical canal, uterine cavity, the entire fallopian tube, and the pelvic and abdominal cavities. For the first time, it realizes the integrated diagnostic function of cervix-uterus-fallopian tube-ovary-pelvic and abdominal cavities. It can complete the comprehensive assessment of complex gynecological diseases without changing equipment, greatly improving diagnostic efficiency.

[0014] 2. On the one hand, this invention integrates high-precision biopsy forceps at the lens end, which, together with real-time high-definition imaging, can accurately complete tissue sampling in the uterine cavity, fallopian tubes, and abdominal cavity (such as puncture biopsy of pelvic and abdominal masses), providing complete and representative samples for pathological examination and ensuring the accuracy of lesion nature determination. On the other hand, by adding a green light source to the optical imaging system, abnormal blood vessels in the lesion area can be accurately detected. Abnormal blood vessels are one of the important characteristics of malignant tumors. This significantly improves the early diagnosis rate of malignant tumors and provides a key basis for the formulation of subsequent treatment plans.

[0015] 3. This invention can replace the traditional laparoscopic pelvic and abdominal cavity exploration function, eliminating the need for general anesthesia, effectively avoiding the risks of anesthesia and the trauma of laparoscopic surgery, and reducing postoperative pain and recovery time for patients; at the same time, the integrated diagnostic mode avoids the trouble of patients undergoing multiple different examinations, reduces the overall diagnosis and treatment costs, and alleviates the physical and economic burden on patients.

[0016] 4. This invention, through the combined design of "optical magnification system + small-diameter imaging fiber + image sensor", can still magnify the image through the optical system even when the diameter of the imaging fiber is smaller than the size of the image sensor. This solves the problem of the excessively large outer diameter of the insertion tube in existing electronic hysteroscopes, ensuring operational flexibility, while also combining the slim advantages of fiber optic endoscopes with the high-definition imaging advantages of electronic endoscopes. At the same time, the flexible endoscope body is made of high-performance materials such as silicone or polyurethane, and with the external operating mechanism, it can achieve 360° precise bending, which can adapt to the complex anatomical structures of the uterine cavity, fallopian tubes and abdominal cavity, improving the convenience of operation for doctors.

[0017] The above description is merely an overview of the technical solution of the present invention. In order to better understand the technical means of the present invention and to implement it in accordance with the contents of the specification, and to make the above and other objects, features and advantages of the present invention more apparent and understandable, preferred embodiments are described in detail below with reference to the accompanying drawings. Attached Figure Description

[0018] Figure 1 This is a visual flowchart of this embodiment. Detailed Implementation

[0019] The present invention will now be further described in conjunction with the accompanying drawings and specific embodiments. It should be noted that, without conflict, the various embodiments or technical features described below can be arbitrarily combined to form new embodiments.

[0020] It should be noted that when a component is described as "fixed to" another component, it can be directly on the other component or may have a component in between. When a component is considered "connected to" another component, it can be directly connected to the other component or may have a component in between. When a component is considered "set on" another component, it can be directly set on the other component or may have a component in between. The terms "vertical," "horizontal," "left," "right," and similar expressions used in this document are for illustrative purposes only.

[0021] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items. Example

[0022] This embodiment, based on the Olympus OTV-SC2 endoscopic camera system, the Olympus electronic digestive endoscope and its core technical parameters, and combined with actual clinical use, clarifies the detailed structure and parameter configuration of the multifunctional flexible hysteroscope.

[0023] 1. Core components and parameters (1) Optical imaging system Camera sensor: Referring to the Olympus OTV-SC2 endoscope camera system, it adopts a 1 / 3-inch high-performance CCD sensor with a resolution of 1920×1080 pixels, supports 30fps real-time image acquisition, and ensures that the fine structures in the uterine cavity, fallopian tubes and abdominal cavity (such as endometrial glands and blood vessel textures) are clearly displayed. Light source system: integrates a cold LED light source (main light source, color temperature 5600K, illuminance ≥800 lux) and a green auxiliary light source (wavelength 520-530nm). The main light source provides uniform illumination through a beam guide (referring to the beam guide glass of the Olympus electronic digestive endoscope, diameter 1.2mm). The green light source is used to highlight abnormal blood vessels (such as tumor-feeding blood vessels). The brightness of the light source can be automatically adjusted by an electronic aperture (adjustment range 100-800 lux) to avoid strong light burning tissue. Optical magnification system: It is equipped with a magnification module consisting of two sets of aspherical lenses, with a magnification of 1.5-3 times. The end of the imaging fiber (0.8mm in diameter) is located on the object plane of the lens, and the CCD sensor is located on the image plane. This solves the contradiction between "thin insertion tube + high-definition imaging". The outer diameter of the insertion tube is controlled at 5.5-6mm (smaller than the 7-8mm of the existing electronic hysteroscope). Transmission line: Shielded coaxial cable, 2.5m in length, supports high-definition digital video signal (HDMI protocol) transmission, latency ≤50ms, ensuring smooth real-time video playback.

[0024] (2) Flexible mirror body Structural design: Referring to the Olympus electronic digestive endoscope, it is divided into a curved section (30mm in length), an insertion tube (1200-1500mm in length, meeting the exploration needs of "uterine cavity → fallopian tube → abdominal cavity"; the length of the insertion tube of the existing flexible endoscope is usually 800-1000mm), an operating section, a light guide tube (500mm in length), and a light guide plug rod. Material selection: The insertion tube and bending part are made of medical polyurethane (ShoreA hardness 70±5), which has both flexibility and bending resistance, and can withstand repeated bending of 360° (bending radius ≥10mm) without breaking; the light guide tube is made of silicone material, which is easy for doctors to hold and operate. Control mechanism: The operating section has two knobs (to control up and down and left and right bending respectively). The knobs can rotate from 0 to 180°, corresponding to bending angles of 0 to 360°. The knobs have a locking button to prevent accidental activation during operation that could cause the mirror to shift.

[0025] (3) Biopsy forceps Structural parameters: The clamp head is made of 304 medical stainless steel, and the surface is electrolytically polished (roughness Ra≤0.2μm) to avoid damage to the working channel of the endoscope; the outer spring tube (diameter 2.0mm) is coated with polytetrafluoroethylene and can be bent synchronously with the endoscope; the clamp head has a cup-shaped structure with a cup diameter of 3.0mm, a cup gap ≤0.03mm, and a biting force ≥5N (achieved through a rigid four-bar structure); all connecting parts are laser welded (weld point diameter 0.5mm), and the tensile strength is ≥100N; Operational adaptation: The biopsy forceps are inserted into the working channel (2.2mm in diameter) through the forceps seat of the operating part. The opening, closing and rotation (rotation angle 0-360°) are controlled by the operating lever. The length of the forceps head extending beyond the lens end during sampling is adjustable (0-15mm) to adapt to the sampling needs of different parts (such as the isthmus of the fallopian tube, pelvic and abdominal masses).

[0026] (4) Auxiliary function components The operating unit is integrated with four remote control buttons (which control image freeze, green light switching, magnification adjustment, and aspiration / injection switching respectively), an aspiration seat (connected to a negative pressure aspiration device, with a negative pressure range of -50 to -200 mmHg), and a water-air seat (connected to a saline / carbon dioxide gas source, with a water flow rate of 5-10 mL / min and an air pressure of ≤15 mmHg), meeting the needs of cleaning the field of vision (absorption of effusion) and expanding the uterine cavity / abdominal cavity (injection of water / air).

[0027] To verify the feasibility and superiority of the multifunctional flexible hysteroscope in this embodiment, a controlled experiment was designed based on actual clinical use. The experimental subjects, process, data, and indications such as "diagnosis of infertility, abnormal uterine bleeding, pelvic inflammatory disease, and tumors" were included to ensure the authenticity of the data.

[0028] 1. Basic Experimental Information Experimental subjects: Sixty gynecological patients aged 25-45 years who visited the Shenzhen-Shantou Central Hospital of Sun Yat-sen Memorial Hospital, Sun Yat-sen University between January and June 2023 were selected. All patients met one of the following criteria: ① Infertility (suspected fallopian tube obstruction or pelvic adhesions); ② Abnormal uterine bleeding (suspected endometrial polyps or submucosal fibroids); ③ Pelvic mass (suspected ovarian cysts or endometriosis). Grouping method: Patients were randomly divided into an experimental group (30 cases, using the multifunctional flexible hysteroscope of this embodiment) and a control group (30 cases, using the existing flexible hysteroscope + laparoscopy combined examination). There were no statistically significant differences in age and disease type distribution between the two groups (P>0.05), ensuring the fairness of the experiment. Evaluation indicators: ① Exploration range (whether it covers the cervix, uterine cavity, fallopian tubes, and pelvic and abdominal cavities); ② Diagnostic accuracy (with postoperative pathological examination results as the gold standard); ③ Surgical-related indicators (operation time, anesthesia method, and postoperative hospital stay); ④ Patient comfort (postoperative VAS pain score, 0-10 points, with lower scores indicating greater comfort).

[0029] 2. Experimental Procedure (1) Experimental group operation procedure (based on the document "Work Process and Operation Procedure") 1. Preoperative preparation: Check all components of the flexible endoscope (CCD imaging, green light source, biopsy forceps opening and closing, suction / injection function) to ensure they are in normal working order; place the patient in the lithotomy position, disinfect the vagina, and administer local anesthesia (2% lidocaine cervical block anesthesia). 2. Flexible endoscope insertion and positioning: The insertion tube is inserted into the uterine cavity through the vagina. The bend is adjusted by operating the knob. The deep part of the cervical canal (2-3 cm from the external os of the cervix), the endometrium of the uterine cavity (anterior wall, posterior wall, fundus), and the opening of the fallopian tube are observed in sequence. Then, the endoscope is controlled to enter the fallopian tube through the opening of the fallopian tube (the smoothness and obstruction of the fallopian tube mucosa are observed throughout the process). Finally, it enters the abdominal cavity to observe the ovary, the serosal surface of the uterus, and the pelvic peritoneum. 3. Imaging observation and biopsy: The main light source is turned on for routine observation. When a suspected lesion is found (such as fallopian tube stenosis or abdominal mass), the green light source is switched to explore abnormal blood vessels. After confirming the lesion, the biopsy forceps are inserted through the forceps holder and samples are taken under the assistance of real-time imaging (1-3 tissue samples are taken per case). 4. Postoperative care: The biopsy forceps are retrieved, and the uterine / peritoneal cavity fluid is removed through the suction seat. The flexible endoscope is slowly removed, and the biopsy sample is sent for pathological examination. The patient is observed for 24 hours postoperatively.

[0030] (2) Control group operation procedure (existing technology) 1. Hysteroscopy: The existing flexible hysteroscope (Olympus HF-290) is used to observe the cervix, uterine cavity, and fallopian tube openings, but it cannot enter the abdominal cavity; 2. Laparoscopic examination: The patient is switched to general anesthesia, and three 0.5-1.0cm incisions are made in the abdomen. A laparoscope is inserted to explore the pelvic and abdominal cavities. If necessary, samples are taken using laparoscopic biopsy forceps. 3. Postoperative care: After laparoscopic removal, the incision is sutured. The patient will be hospitalized for 3-5 days postoperatively. 4. Experimental Conclusions 1. Verification of exploration capabilities: The experimental group achieved integrated exploration of the cervix-uterus-fallopian tubes-pelvic cavity by increasing the length of the endoscope and using a 360° curved design, without the need for laparoscopy, thus verifying the technical objective of "replacing traditional laparoscopic exploration". 2. Verification of diagnostic accuracy: Due to the green light source (for detecting abnormal blood vessels) and the precision biopsy forceps (for high sampling success rate), the experimental group had a significantly higher diagnostic accuracy rate than the control group, verifying the advantage of "increasing the diagnostic rate of malignant tumors". 3. Clinical applicability verification: The experimental group used local anesthesia, had a short operation time, fast postoperative recovery, and less pain, which significantly reduced the patient's medical burden and verified the beneficial effects of "reducing the patient's economic burden and improving patient-friendliness". 4. Verification of operational flexibility: The outer diameter of the insertion tube in the experimental group was only 5.5-6mm, and the bending part was highly controllable. No jamming of the endoscope or tissue damage occurred during operation, which verified the design advantage of "combining the thinness of fiber endoscope with the high definition of electronic endoscope".

[0031] The above embodiments are merely preferred embodiments of the present invention and should not be construed as limiting the scope of protection of the present invention. Any non-substantial changes and substitutions made by those skilled in the art based on the present invention shall fall within the scope of protection claimed by the present invention.

Claims

1. A multifunctional flexible hysteroscope, characterized in that, Includes an optical imaging system, a flexible microscope body, and biopsy forceps integrated within the flexible microscope body; The optical imaging system includes a lens end and a transmission line. The lens end integrates a high-resolution camera sensor and a light source system. The light source system is used to provide illumination for the uterine cavity and abdominal cavity to obtain a clear field of view. One end of the transmission line is connected to the lens end, and the other end is used to connect to an external display device to transmit the digital video signal collected by the camera sensor to the external display device in real time. The flexible endoscope body is made of a material with high flexibility and high flexibility. Its length is configured to be able to enter the abdominal cavity through the fallopian tube. The flexible endoscope body is equipped with an external operating mechanism, which is used to control the bending angle and direction of the flexible endoscope body. The biopsy forceps are integrated into the working channel inside the flexible endoscope. The biopsy forceps are equipped with an external operating mechanism, which is used to control the opening, closing and rotation of the biopsy forceps to complete tissue sampling in the uterine cavity, fallopian tubes and abdominal cavity under the assistance of real-time imaging.

2. The multifunctional flexible hysteroscope according to claim 1, characterized in that, The optical imaging system includes a green light source, which is used to detect abnormal blood vessels in the uterine cavity and abdominal cavity to improve the diagnostic rate of malignant tumors.

3. The multifunctional flexible hysteroscope according to claim 1, characterized in that, The flexible mirror body is made of silicone or polyurethane, and the material can maintain structural stability when subjected to bending and twisting operations.

4. The multifunctional flexible hysteroscope according to claim 1, characterized in that, The biopsy forceps have a head made of medical-grade stainless steel with a smooth surface. The outer spring tube of the biopsy forceps has a plastic-coated structure to avoid damaging the working channel of the flexible endoscope. The biopsy forceps have a rigid four-bar structure with a gap between the forceps head and the cup mouth of less than 0.03 mm. All connecting parts of the biopsy forceps are fixed by laser welding.

5. The multifunctional flexible hysteroscope according to claim 1, characterized in that, The optical imaging system further includes an optical magnification system, which is disposed between the camera sensor and the imaging fiber. The end of the imaging fiber is located at the object plane of the optical magnification system, and the camera sensor is located at the image plane of the optical magnification system. The diameter of the imaging fiber is smaller than the size of the camera sensor.

6. The multifunctional flexible hysteroscope according to claim 1, characterized in that, The external control mechanism is a joystick or control handle, which can drive the flexible endoscope to bend freely in 360° to adapt to the observation and operation needs of different angles in the uterine cavity, fallopian tubes and abdominal cavity.

7. The multifunctional flexible hysteroscope according to claim 1, characterized in that, The high-resolution camera sensor of the optical imaging system is a high-performance CCD, and the optical imaging system is equipped with an electronic aperture. The electronic aperture is used to adjust the light intensity in real time according to the light environment in the uterine cavity and abdominal cavity to ensure the stability of the video signal image quality.

8. The multifunctional flexible hysteroscope according to claim 1, characterized in that, The flexible endoscope body includes a curved section, an insertion tube, an operating section, a light-guiding hose, and a light-guiding plug rod connected in sequence. The front end of the curved section is a tip containing the lens end, and the tip also has a forceps channel communicating with the working channel and a nozzle for water and air injection. The operating section integrates some components of the external operating mechanism and some components of the external operating mechanism. The operating section is equipped with a knob, a remote control button, a suction seat, a water and air seat, and a forceps seat. The knob is used to adjust the direction of the curved section, the remote control button is used to realize image freezing and imaging mode switching functions, the suction seat is used to connect the suction device, the water and air seat is used to connect the water and air injection device, and the forceps seat communicates with the working channel and is used to assist in the assembly and maintenance of the biopsy forceps.

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