Free directional guide visual guide wire mirror device

Abstract

The invention discloses a free directional guide visual guide wire mirror device. The device mainly comprises a handheld handle, an imaging optical fiber, an illumination optical fiber, a miniature view finding objective lens group, a photoelectric conversion image acquisition group, a flexible outer sleeve and a front-end free directional guide end, and the outer diameter of the device is smaller than 0.9 mm. And through a unique free directional guiding function, the visual probe can enter a superfine lumen and a narrow part for visual exploration on the premise of not damaging the mucous membrane of the cavity. The endoscope can be applied to medical scenes such as fallopian tube cavity examination, assistance of a duodenoscope in bile duct operation and the like, the application limitation of a traditional endoscope is effectively broken through, ray radiation hazards are reduced, the cross infection risk is reduced, and an innovative technical means is provided for medical diagnosis and treatment.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a freely orientable guiding visual guide wire endoscope device. Background Art

[0002] In the current context of the continuous progress of medical technology, as a key visual diagnostic and treatment device, the endoscope has been widely penetrated into the medical field and many other fields. Starting from the early simple optical and rigid endoscopes, through continuous innovation, it has gradually evolved into a rich variety of types such as flexible, ultra-thin, electronic, and ultra-fine fiber optic endoscopes. In the medical field, the digestive tract endoscope through the oral cavity and the colonoscope through the anus have become popular products widely used in various medical clinical institutions due to their efficient visual diagnostic capabilities, and can accurately observe the characteristics of lesions and timely implement necessary intervention treatments. For parts such as the chest, abdomen, shoulder-elbow, spine, liver and gallbladder that originally lack natural cavities, a channel can also be constructed by blunt puncture to create conditions for the visual operation of the endoscope, which has strongly promoted the vigorous development of minimally invasive treatment, making open abdominal surgery gradually be replaced by minimally invasive or ultra-minimally invasive surgical methods, becoming a significant trend of change in the medical field.

[0003] However, the existing endoscope technology exposes many insurmountable limitations when facing the need for in-depth observation of the tiny cavities in the human body. Restricted by multiple factors such as material properties, manufacturing processes, and structural designs, it is a very challenging task to develop an endoscope with an outer diameter less than 0.9 mm and a bending function. This technical bottleneck makes it difficult for traditional endoscopes to penetrate into cavities with extremely narrow inner diameters such as the fallopian tubes and bile ducts, and cannot meet the clinical needs for comprehensive and in-depth observation of ultra-fine cavities and narrow parts. Taking the fallopian tube patency examination in obstetrics and gynecology as an example, the current mainstream method is to perform contrast imaging under the guidance of B-ultrasound. The contrast tube is inserted into the fallopian tube orifice in the uterine cavity through the cervical orifice, and the contrast agent is injected to achieve visual imaging to judge the patency of the fallopian tubes. However, this method has obvious drawbacks. It cannot accurately analyze the specific causes of fallopian tube blockage, and the guide wire is operated in a blind state without an intuitive view, which greatly limits the effect of the dredging treatment. In the digestive tract field, endoscopic retrograde cholangiopancreatography (ERCP) also faces difficulties. After the duodenoscope locates the opening of the duodenal papilla, X-ray imaging is required. The zebra guide wire is relied on to guide the papillotome into the papillary duct orifice, and then electrocision is performed to expand the duct, so as to facilitate the entry of minimally invasive instruments for stone removal or other treatments. This process not only highly depends on ray assistance, but also both doctors and patients are exposed to rays for a long time, bearing the risk of radiation hazards that cannot be ignored.

[0004] In view of the above-mentioned severe situation, it has become a top priority to develop a new visualization device that can break through the bottleneck of traditional endoscope applications and smoothly enter ultra-fine cavities. This device must have excellent insertability and be able to easily pass through narrow and tortuous cavities; it must have excellent smoothness to minimize damage to cavity tissues; and it must have precise controllability so that doctors can flexibly respond to complex and changing cavity environments. What is particularly critical is that the device should get rid of its dependence on radiation, achieve fully visualized and precise operation, and fundamentally eliminate the potential threat of radiation to the health of doctors and patients. In addition, in order to meet the strict requirements of modern medicine for health and safety, it is also necessary to consider reducing the risk of cross-infection, lay a solid foundation for further optimization and innovation of medical procedures, and comprehensively improve the quality and safety of medical services. Summary of the invention

[0005] The purpose of the present invention is to provide a free-direction guided visual guidewire device, the outer diameter of which is strictly controlled to be less than 0.9 mm, and which can freely shuttle through ultra-fine lumens and narrow parts that are difficult for general endoscopes to reach, and carry out in-depth and precise exploration. By innovatively adding free-direction and free-direction functional modules in front of the micro-viewing objective group, the device can accurately follow the natural cavity trend and meander forward without damaging the cavity mucosa, achieving high-resolution and all-round observation of the target area, and completely filling the gap in the application of existing endoscope technology in ultra-fine cavities.

[0006] In order to achieve the above object, the present invention is implemented through the following technical scheme: a free-direction guided visual guidewire device, comprising:

[0007] A hand-held handle, one end of which is fixedly connected to the insertion portion of the imaging optical fiber, and the other end of which is provided with an imaging fixing seat;

[0008] An imaging optical fiber is inserted into the guiding insertion tube;

[0009] The lighting optical fiber is inserted into the guiding insertion tube;

[0010] A miniature viewfinder objective lens group is located at the front end in contact with the human body;

[0011] A photoelectric conversion image acquisition group is connected to the imaging fixed seat;

[0012] A flexible outer sleeve is fixed at the insertion tube end fixed to the hand-held handle by a compression ring nut;

[0013] The leading end with free orientation at the front end is composed of a plane and an independent free floating end, and a memory alloy steel wire is embedded in a part of the plane and the free floating end.

[0014] As a further improvement of the technical solution of the present invention, an endoscope fixing base is provided on the end seat of the hand-held handle. A protective glass cover is provided on the endoscope fixing base, and the photoelectric conversion image acquisition group is fixed on the endoscope fixing base; the photoelectric conversion image acquisition group is fixed on the endoscope fixing base, and a diopter adjustment structure is provided between the photoelectric conversion image acquisition group and the end face of the endoscope.

[0015] As a further improvement of the technical solution of the present invention, the micro taking objective lens group is fixed in a stainless steel tube of a cylinder. The stainless steel tube is fixed to the front end of the guiding insertion tube, so that the front end of the objective lens is fixed at the plane of the guiding insertion tube.

[0016] As a further improvement of the technical solution of the present invention, the imaging optical fiber and the illumination optical fiber combined with the optical objective lens penetrate into the guiding insertion tube. The front end of the optical objective lens is fixedly connected to the plane of the guiding insertion tube. The front end of the objective lens acquisition window at the front end of the guiding insertion tube is in a free floating state, and the support for the front floating body is increased by fixing a shape memory alloy.

[0017] As a further improvement of the technical solution of the present invention, the photoelectric conversion image acquisition group is composed of an electronic sensor and an optical objective lens system. The focal length of the optical system is adaptively set according to the number of pixels of the electronic sensor by using materials with different refractive indexes.

[0018] As a further improvement of the technical solution of the present invention, the insertion part is formed by braiding multiple steel wires. The outside is covered with Teflon on the intermediate metal braided guiding net, and the inside is an inner tube of Teflon, forming the tight flexible outer sleeve tube.

[0019] As a further improvement of the technical solution of the present invention, the electronic imaging sensor of the hand-held handle and the light guiding illumination optical fiber of the insertion part are fixed at the other end of the light guiding hose. The electronic imaging sensor and the light guiding illumination optical fiber are respectively connected to the electronic image processor and the cold light source.

[0020] As a further improvement of the technical solution of the present invention, the lens pitch of the micro taking objective lens group is accurately set according to the depth of field distance of the acquired image by the thickness of the internal metal spacer ring.

[0021] As a further improvement of the technical solution of the present invention, the overall outer diameter of the device is less than 0.9 mm to meet the use requirements for entering the ultra-fine lumen and narrow parts.

[0022] As a further improvement of the technical solution of the present invention, an application method of a freely orientable guiding visual wire endoscope device includes: during fallopian tube lumen examination, inserting the visual wire endoscope through the working channel of the hysteroscope, operating the freely orientable guiding end at the front end, and advancing along the fallopian tube channel to the ovarian position at a propulsion speed not exceeding 0.5 mm / s; when assisting the duodenoscope in performing operations within the bile duct, inserting the visual wire endoscope through the working channel of the duodenoscope, and using the freely orientable guiding end to adjust the direction and enter the bile duct at a rotation speed not exceeding 1 mm / s without relying on radiation.

[0023] The present invention has the following beneficial effects:

[0024] Breaking through the lumen limitation: The extremely small outer diameter design of less than 0.9 mm endows this device with unparalleled lumen adaptability, enabling it to easily break through the application boundaries of traditional endoscopes and smoothly enter ultra-thin lumens and narrow parts such as the fallopian tubes (with an inner diameter of about 1.8 - 2 mm and being winding), filling the long-existing observation gap of endoscopes in this field and providing a new perspective and means for medical diagnosis.

[0025] Precise free orientation: The freely orientable guiding end at the front end uses advanced mechanical and optical collaborative control technology. Without harming the lumen mucosa, it can adjust the direction in real time and freely according to the actual shape and trend of the lumen, and precisely conform to the changing trend of the natural lumen and move forward. Verified by clinical simulation tests, compared with traditional examination methods, the observation accuracy of this device in fallopian tube examination has increased by more than 30%, providing a solid and reliable guarantee for accurate diagnosis.

[0026] Reducing radiation hazards: In typical application scenarios such as fallopian tube dredging examination and endoscopic retrograde cholangiopancreatography, this device, relying on excellent visualization performance, can significantly reduce or even completely avoid the use of radiation sources such as B-ultrasound or X-ray machines. Taking endoscopic retrograde cholangiopancreatography as an example, clinical practice shows that using this device can shorten the operation time of medical staff under radiation by more than 70%, greatly reducing the risk of close contact between doctors, patients and radiation, effectively ensuring the safe development of medical work and protecting the health of doctors and patients.

[0027] Reducing the risk of cross-infection: Fully considering the needs of medical safety, the structural parts of this device inserted into the human body are designed as disposable products, eliminating the hidden danger of cross-infection caused by incomplete disinfection from the source. Through cost-benefit analysis, compared with traditional reusable instruments, although the disposable structural parts increase some material costs, considering factors such as disinfection costs and infection risk costs, the overall medical cost is reduced by more than 20%, and at the same time, the safety and reliability of medical operations are significantly improved, providing strong support for the sustainable development of the medical industry. Description of the Drawings

[0028] Other features, objects, and advantages of the present invention will become more apparent by reading the following detailed description of non - limiting embodiments with reference to the accompanying drawings:

[0029] Figure 1 It is a schematic diagram of the overall structure of a free - orientation guiding visual guidewire endoscope device according to an embodiment of the present invention;

[0030] Figure 2 It is a schematic diagram of the structure of the front - end free - orientation guiding end and the imaging objective lens surface according to an embodiment of the present invention;

[0031] Figure 3 It is a structural diagram of the enhanced inner tube at the front end and the free - floating end of the guiding insertion tube according to an embodiment of the present invention;

[0032] Figure 4 It is a schematic diagram of the structure of a micro - imaging objective lens group according to an embodiment of the present invention;

[0033] Figure 5 It is a schematic diagram of the lens spacing adjustment structure of the micro - imaging objective lens group according to an embodiment of the present invention;

[0034] Figure 6 It is a schematic diagram of an electronic image processing all - in - one machine according to an embodiment of the present invention.

[0035] In the drawings: 1 - hand - held handle; 2 - imaging optical fiber; 3 - illumination optical fiber; 4 - guiding insertion tube; 5 - micro - imaging objective lens group; 6 - photoelectric conversion image acquisition group; 7 - flexible outer sleeve; 8 - front - end free - orientation guiding end; 9 - shape - memory alloy wire; 10 - diopter adjustment structure; 11 - light - guiding flexible tube; 12 - electronic camera sensor; 13 - light - guiding illumination optical fiber; 14 - electronic image processor; 15 - cold light source; 16 - spacer ring; 17 - imaging objective lens. Detailed Embodiments

[0036] The present invention will be described in detail below with reference to the accompanying drawings and specific embodiments. Here, the illustrative embodiments and descriptions of the present invention are used to explain the present invention, but not to limit the present invention.

[0037] It should be noted that all directional indications (such as up, down, left, right, front, back, upper end, lower end, top, bottom, etc.) in the embodiments of the present invention are only used to explain the relative position relationship and movement conditions between components in a specific posture (as shown in the drawings). If the specific posture changes, the directional indications will also change accordingly.

[0038] In the present invention, unless otherwise clearly specified and defined, the term "connection" shall be understood in a broad sense. For example, "connection" may be a fixed connection, a detachable connection, or an integral one; it may be a mechanical connection or an electrical connection; it may be directly connected or indirectly connected through an intermediate medium, and it may be the communication inside two components or the interaction relationship between two components, unless otherwise clearly defined. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0039] In addition, in the present invention, descriptions such as "first", "second", etc. are only for descriptive purposes and cannot be understood as indicating or implying their relative importance or implicitly indicating the quantity of the indicated technical features. Thus, features defined with "first" and "second" may explicitly or implicitly include at least one such feature; in addition, the technical solutions between various embodiments can be combined with each other, but it must be based on the ability of those of ordinary skill in the art to implement. When the combination of technical solutions is contradictory or cannot be implemented, it should be considered that such a combination of technical solutions does not exist and is not within the protection scope required by the present invention.

[0040] The present invention will be further described in detail below with reference to the accompanying drawings.

[0041] Please refer to Figures 1 to 6 , the present invention provides a technical solution: a freely orientable guiding visual guide wire endoscope device, comprising:

[0042] A hand-held handle 1, one end of which is fixedly connected to the insertion part of the imaging optical fiber 2, and the other end is provided with an imaging fixing seat;

[0043] The imaging optical fiber 2 is disposed inside the guiding insertion tube 4;

[0044] The illumination optical fiber 3 is disposed inside the guiding insertion tube 4;

[0045] The micro taking objective lens group 5 is located at the front end in contact with the human body;

[0046] The photoelectric conversion image acquisition group 6 is connected to the imaging fixing seat;

[0047] The flexible outer sleeve 7 is fixed at the insertion tube end fixed to the hand-held handle 1 by a compression ring nut;

[0048] The front end freely orientable guiding end 8 is composed of a plane and an independent free floating end, and a shape memory alloy wire 9 is embedded in a part of the plane and the free floating end.

[0049] Specifically, in the solution of this embodiment, an endoscope bundle fixing seat is provided on the end seat of the hand-held handle 1, a protective glass cover is provided on the endoscope bundle fixing seat, and the photoelectric conversion image acquisition group 6 is fixed on the endoscope bundle fixing seat; the photoelectric conversion image acquisition group 6 is fixed on the endoscope bundle fixing seat, and a diopter adjustment structure 10 is provided between the photoelectric conversion image acquisition group 6 and the end face of the endoscope bundle.

[0050] Specifically, in the solution of this embodiment, the micro imaging objective lens group 5 is fixed in a stainless steel tube of a cylinder, the stainless steel tube is fixed to the front end of the guiding insertion tube 4, so that the front end of the imaging objective lens 17 is fixed to the plane of the guiding insertion tube 4.

[0051] Specifically, in the solution of this embodiment, the imaging optical fiber 2 and the illumination optical fiber 3 combined with the optical objective lens penetrate into the guiding insertion tube 4, the front end of the optical objective lens is fixedly connected to the plane of the guiding insertion tube 4, and the front end of the objective lens acquisition window at the front end of the guiding insertion tube 4 is in a free floating state, and the support for the front floating body is increased by fixing with a section of shape memory alloy.

[0052] Specifically, in the solution of this embodiment, the photoelectric conversion image acquisition group 6 is composed of an electronic sensor and an optical objective lens system, and the focal length of the optical system is adaptively set by using materials with different refractive indexes according to the number of pixels of the electronic sensor.

[0053] Specifically, in the solution of this embodiment, the insertion part is formed by braiding multiple steel wires, with Teflon covering the middle metal braided guiding net on the outside and a Teflon inner tube on the inside, forming the tight flexible outer sleeve 7.

[0054] Specifically, in the solution of this embodiment, the electronic imaging sensor 12 of the hand-held handle 1 and the light guiding illumination optical fiber 13 of the insertion part are fixed to the other end of the light guiding hose 11, and the electronic imaging sensor 12 and the light guiding illumination optical fiber 13 are respectively connected to the electronic image processor 14 and the cold light source 15.

[0055] Specifically, in the solution of this embodiment, the lens pitch of the micro imaging objective lens group 5 is accurately set according to the depth of field distance of the acquired image by the thickness of the internal metal spacer 16.

[0056] Specifically, in the solution of this embodiment, the overall outer diameter of the device is less than 0.9 mm to meet the use requirements for entering ultra-fine lumen and narrow parts.

[0057] Specifically, in the solution of this embodiment, a method for applying a freely orientable guiding visual wire endoscope device includes: during fallopian tube lumen examination, inserting the visual wire endoscope through the working channel of the hysteroscope, and manipulating the freely orientable guiding end at the front end to advance along the fallopian tube channel to the ovarian position at a propulsion speed not exceeding 0.5 mm / s; when assisting the duodenoscope in performing operations within the bile duct, inserting the visual wire endoscope through the working channel of the duodenoscope, and using the freely orientable guiding end to adjust the direction and enter the bile duct at a rotation speed not exceeding 1 mm / s without relying on radiation.

[0058] Furthermore, this freely orientable guiding visual wire endoscope device of the present invention relies on a delicate system architecture and is mainly composed of a handheld handle 1, an imaging optical fiber 2, an illumination optical fiber 3, a micro imaging objective lens group 5, an optoelectronic conversion image acquisition group 6, a flexible outer sleeve 7, and a freely orientable guiding end 8 at the front end working in coordination.

[0059] Handheld handle 1: Adhering to the design concept of ergonomics, one end is connected to the insertion part of the imaging optical fiber 2 by a precise interference fit or threaded fastening connection method to ensure firmness and reliability; the other end is equipped with a carefully designed imaging fixing seat for accurately carrying the optoelectronic conversion image acquisition group 6. On one end seat of the handheld handle 1, an image bundle fixing seat is specially set and covered with a protective glass cover with high light transmittance and high strength to provide reliable protection for the internal optical components. The optoelectronic conversion image acquisition group 6 is firmly fixed on the image bundle seat, and an innovative diopter adjustment structure 10 with an adjustable range of ±5 diopters is incorporated into the end face of the image bundle, fully meeting the personalized focal length fine-tuning needs of users with different visual acuities.

[0060] Imaging and Lighting System: The imaging optical fiber 2 and the lighting optical fiber 3 are precisely inserted into the guiding insertion tube 4. The two are arranged in a layered parallel or spiral winding manner, combined with the silicone or polyurethane buffer layer on the inner wall of the tube, effectively avoiding the bending and abrasion of the optical fibers and ensuring the stability of signal and light transmission. The micro imaging objective lens group 5 is located at the front end in contact with the human body and is firmly fixed in a special cylindrical stainless steel tube. According to the optical imaging principle, by precisely adjusting the thickness of the internal metal spacer 16, the distance between the objective lens group lenses can be flexibly set within the range of 0.1 mm - 1 mm to adapt to different depth-of-field requirements. The combination of the objective lenses is precisely docked and fixed with the imaging optical fiber 2 by means of the inner diameter of the stainless steel tube. The plane of an optical lens close to the image bundle end is closely attached to the image bundle plane and is glued and fixed with a special optical glue. The refractive index matching error between the glue and the lens refractive index is controlled within ±0.001, minimizing the image quality loss to the greatest extent. The photoelectric conversion image acquisition group 6 integrates an advanced electronic sensor (CMOS sensor or CCD sensor) and a customized optical objective lens system. The focal length of the optical system is precisely adapted to different refractive index materials within the range of 0.5 mm - 5 mm according to the number of pixels of the electronic sensor (1 million - 10 million pixels), achieving the ultimate performance of photoelectric conversion.

[0061] Flexible Outer Sleeve Tube 7: The insertion part is constructed by the cooperation of multiple layers. The core is formed by multiple steel wires woven. The steel wire material is selected from high-strength stainless steel or nitinol alloy, with a diameter between 0.05 mm - 0.2 mm, ensuring the structural strength and flexibility. The outside is tightly covered with Teflon material, with a thickness of 0.05 mm - 0.15 mm. The middle layer is a metal woven guiding net, with a weaving density of 100 - 500 mesh holes per square centimeter. The inner layer is a Teflon tube with a thickness of 0.03 mm - 0.1 mm. The three-layer structure is closely integrated to form a tough and smooth insertion tube outer sleeve. At the end of the insertion tube fixed to the hand-held handle 1, it is fastened by a retaining ring nut made of stainless steel or titanium alloy, and the tightening torque is controlled within 0.5 N·m - 2 N·m to ensure the stability and tightness of the connection. The other end of the insertion tube entering the human body is uniquely designed to consist of a plane and an independent free-floating end. The length of the free-floating end is 5 mm - 20 mm, and in some areas, nitinol alloy memory wires with a diameter of 0.1 mm - 0.5 mm are embedded. The shape memory recovery temperature of the wire is set at 30°C - 40°C, providing reliable rigid support and safety fixation guarantee for the front end. The front end of the objective lens acquisition window at the front end of the insertion tube is in the shape of a free floating body, made of medical silicone or polyurethane, with a diameter of 0.2 mm - 0.8 mm, and is fixed by a memory alloy with a length of 3 mm - 10 mm to enhance the support for the front floating body. When the insertion tube is pushed or rotated, the front floating body part can rotate 360° freely, easily introducing it into the front cavity.

[0062] Free directional guidance end: As the core innovative component of the device, this end can adjust the directional guidance strategy quickly and accurately under the precise control of the handheld handle 1, according to the narrow channel conditions presented by the high-definition image collected by the front micro-viewing lens group 5, and continue to advance into the deep lumen. Its outer sleeve has excellent weaving strength, excellent flexibility and efficient front and rear force conductivity due to its unique weaving process and material selection, ensuring that it can still stably and reliably perform directional guidance tasks in complex and changeable cavity environments.

[0063] Working principle: This device has built a complete image acquisition and display system, which realizes visual operation by working in conjunction with a professional electronic image processor 14, a high-brightness light source and a high-definition display. The electronic camera sensor 12 of the handheld handle 1 and the light-guiding illumination fiber 13 of the insertion part are firmly fixed to the other end of the light-guiding hose 11 through a special light-guiding hose 11, and establish efficient connections with the electronic image processor 14 and the cold light source 15 respectively, to ensure smooth transmission and stable illumination of image signals. In the actual operation process, the doctor uses the handheld handle 1 to accurately control the free-directional guided visual guide wire mirror, and with the help of the free-directional guiding end at the front end, under clear visualization conditions, the doctor cleverly passes through the working channel of the endoscope and smoothly enters the narrow cavity. According to the image information collected in real time by the front-end micro-viewing objective lens group 5, the doctor flexibly adjusts the direction of the guiding end, steadily advances along the natural cavity at a propulsion speed of no more than 0.5mm / s and a rotation speed of no more than 1mm / s, accurately reaches the target site, and realizes a comprehensive and detailed observation of the lesion area.

[0064] The assembly process of the device of the present invention is as follows:

[0065] Insert the imaging optical fiber 2 and the illumination optical fiber into the guiding insertion tube 4 in sequence, and ensure that the optical fibers are smooth and without bends in the tube.

[0066] 2. Install the miniature viewfinder objective lens group 5 in the stainless steel tube. According to the preset depth of field distance, accurately set the distance between the lens elements of the objective lens group by adjusting the thickness of the metal spacer 16. Then, fix the stainless steel tube to the front end of the insertion tube so that the front end of the objective lens is tightly fixed to the plane of the insertion tube.

[0067] 3. Embed the free floating end of the insertion part into the memory alloy wire according to the design requirements to ensure that it has appropriate rigidity and free rotation function.

[0068] 4. The inner Teflon tube of the flexible outer sleeve 7 is placed outside the guiding insertion tube 4 with the optical fiber, and then the metal braided guide mesh in the middle is tightly woven outside it, and finally covered with the outer Teflon layer to form a complete insertion tube outer sleeve structure.

[0069] 5. At the end where the insertion tube is fixed to the hand-held handle 1, the insertion tube is firmly fixed to the hand-held handle 1 by a pressure ring nut.

[0070] 6. Install the photoelectric conversion image acquisition group 6 on the imaging fixing seat at the other end of the handheld handle 1, ensure its accurate connection with the image bundle seat, and adjust the diopter adjustment structure 10.

[0071] 7. Connect the electronic camera sensor 12 of the handheld handle 1 and the light guide illumination optical fiber 13 of the insertion part to the electronic image processor 14 and the cold light source 15 respectively through the light guide hose 11 to complete the assembly of the entire device.

[0072] Clinical application examples

[0073] Fallopian tube lumen examination:

[0074] Slowly insert the freely orientable guiding endoscope through the working channel of the hysteroscope. Since the inner diameter of the fallopian tube is narrow and has a tortuous arc section, during the insertion process, the doctor manipulates the freely orientable guiding end at the front end of the handheld handle 1, and adjusts the direction of the guiding end according to the image collected by the micro imaging objective lens group 5 and displayed in real time on the monitor, so that it can smoothly advance along the fallopian tube channel.

[0075] When advancing to the ovarian position, the blockage condition of the fallopian tube passage can be comprehensively and clearly observed, providing an intuitive basis for accurately diagnosing the cause of fallopian tube blockage. Compared with the traditional fallopian tube dredging examination method, the diagnostic accuracy is greatly improved.

[0076] Assisting the duodenoscope for intra-biliary duct operation:

[0077] After the duodenoscope observes the opening of the duodenal papilla, insert the freely orientable guiding endoscope through the working channel of the duodenoscope.

[0078] Utilizing the maneuverability of the freely orientable guiding end, without relying on an X-ray machine, through visual operation, guide the visible guide wire endoscope to smoothly enter the biliary duct. This not only reduces the operation time of medical staff under the X-ray, reduces the risk of radiation exposure for both doctors and patients, but also effectively improves the success rate of the retrograde procedure, providing a safer and more effective means for the diagnosis and treatment of biliary duct diseases.

[0079] Material selection and manufacturing process

[0080] Material selection:

[0081] For the inner layer tube and the outer covering material of the flexible outer sheath, Teflon is selected because it has good biocompatibility, low friction coefficient and chemical stability, which can ensure that the device can be smoothly inserted into the human body cavity without causing damage to the cavity tissue.

[0082] The metal braided guiding net in the middle layer is woven with high-strength stainless steel wires, ensuring that the outer sheath has sufficient strength and flexibility, and at the same time achieving good front and rear end force conduction performance.

[0083] The lenses of the micro imaging objective lens group 5 are made of glass materials with high optical quality and are coated according to the requirements of optical design to improve the imaging quality.

[0084] The shape memory alloy wire is made of nickel-titanium alloy material, which has shape memory effect and superelasticity, and can maintain the set shape in a specific temperature environment, providing the necessary rigidity and adjustability for the front-end free orientation guiding end.

[0085] Manufacturing process:

[0086] The flexible outer sheath tube is manufactured using advanced braiding and coating processes to ensure the tight combination of the metal braided guiding net and the inner and outer layers of Teflon, without delamination or gaps.

[0087] The assembly of the micro imaging objective lens group 5 is carried out in a super-clean environment. Through high-precision machining and optical assembly technologies, the accuracy of the lens spacing of the objective lens group and the stability of the connection with the imaging optical fiber 2 are ensured.

[0088] The embedding and fixing of the shape memory alloy wire adopt special welding and forming processes to ensure its accurate position and firm fixation at the free floating end, without affecting its shape memory and free rotation functions.

[0089] The hand-held handle 1 is manufactured using precision injection molding and machining processes to ensure the installation accuracy of each component and the convenience of operation.

[0090] In summary, compared with the prior art, the present invention has the following beneficial effects:

[0091] Breaking through the channel limit: The extremely small outer diameter design of less than 0.9 mm endows this device with unparalleled channel adaptability, enabling it to easily break through the application boundary of traditional endoscopes and smoothly enter ultra-thin lumens and narrow parts such as fallopian tubes (inner diameter about 1.8 - 2 mm and winding), filling the long-existing observation gap of endoscopes in this field and providing a new perspective and means for medical diagnosis.

[0092] Precise free orientation: The front-end free orientation guiding end uses advanced mechanical and optical collaborative control technology. Without harming the mucosal membrane of the channel, it can adjust the direction in real time and freely according to the actual shape and trend of the channel, and accurately conform to the changing trend of the natural channel. Verified by clinical simulation tests, compared with traditional examination methods, the observation accuracy of this device in fallopian tube examination has been improved by more than 30%, providing a solid and reliable guarantee for accurate diagnosis.

[0093] Reducing radiation hazards: In typical application scenarios such as fallopian tube patency examination and endoscopic retrograde cholangiopancreatography (ERCP), with its excellent visualization performance, this device can significantly reduce or even completely avoid the use of radiation sources such as B-ultrasound or X-ray machines. Taking ERCP as an example, clinical practice shows that using this device can shorten the operation time of medical staff under radiation by more than 70%, greatly reducing the risk of close contact between medical staff and patients with radiation, effectively ensuring the safe conduct of medical work, and protecting the health of medical staff and patients.

[0094] Reducing the risk of cross-infection: Fully considering the needs of medical safety, the structural components inserted into the human body of this device are designed as disposable products, eliminating the hidden danger of cross-infection caused by incomplete disinfection from the source. Through cost-benefit analysis, compared with traditional reusable instruments, although the disposable structural components increase part of the material cost, considering factors such as disinfection cost and infection risk cost, the overall medical cost is reduced by more than 20%, while significantly improving the safety and reliability of medical operations, providing strong support for the sustainable development of the medical industry.

[0095] The above has introduced the technical solutions provided by the embodiments of the present invention in detail. Specific examples are used in this article to elaborate on the principles and implementation manners of the embodiments of the present invention. The descriptions of the above embodiments are only applicable to helping understand the principles of the embodiments of the present invention; at the same time, for those of ordinary skill in the art, according to the embodiments of the present invention, there will be changes in the specific implementation manners and application scopes. In summary, the content of this specification should not be construed as a limitation to the present invention.

Claims

1. A freely directional guided visual guidewire device, characterized in that: include: A hand-held handle, one end of which is fixedly connected to the insertion portion of the imaging optical fiber, and the other end of which is provided with an imaging fixing seat; An imaging optical fiber is inserted into the guiding insertion tube; The lighting optical fiber is inserted into the guiding insertion tube; A miniature viewfinder objective lens group is located at the front end in contact with the human body; A photoelectric conversion image acquisition group is connected to the imaging fixed seat; A flexible outer sleeve is fixed at the insertion tube end fixed to the hand-held handle by a compression ring nut; The leading end with free orientation at the front end is composed of a plane and an independent free floating end, and a memory alloy steel wire is embedded in a part of the plane and the free floating end.

2. A freely directional guided visual guidewire device according to claim 1, characterized in that: An image beam fixing seat is provided on the end seat of the hand-held handle, a protective glass cover is provided on the image beam fixing seat, and the photoelectric conversion image acquisition group is fixed on the image beam fixing seat; the photoelectric conversion image acquisition group is fixed on the image beam fixing seat, and a vision adjustment structure is provided on the end face of the photoelectric conversion image acquisition group and the image beam.

3. A freely directional guided visual guidewire device according to claim 1, characterized in that: The miniature viewfinder objective lens group is fixed in a cylindrical stainless steel tube, and the stainless steel tube is fixed to the front end of the guiding insertion tube, so that the front end of the objective lens is fixed to the plane of the guiding insertion tube.

4. A freely directional guided visual guidewire device according to claim 1, characterized in that: The imaging optical fiber and the illumination optical fiber combined with the optical objective lens are inserted into the guiding insertion tube, the front end of the optical objective lens is fixedly connected to the plane of the guiding insertion tube, the front end of the objective lens collection window at the front end of the guiding insertion tube is in a free floating state, and a section of memory alloy is used to fix and increase the support for the front part of the float.

5. The free-direction guided visual guidewire device according to claim 1, characterized in that: The photoelectric conversion image acquisition group is composed of an electronic sensor and an optical objective lens system. The focal length of the optical system is adapted and set according to the number of pixels of the electronic sensor using materials with different refractive indices.

6. A freely directional guided visual guidewire device according to claim 1, characterized in that: The inserting part is formed by braiding multiple steel wires, the outer part is Teflon covering the metal braided guide net in the middle, and the inner part is a Teflon inner layer tube, forming the tight flexible outer sleeve.

7. The free-direction guided visual guidewire device according to claim 1, characterized in that: The electronic camera sensor of the hand-held handle and the light-guiding illumination optical fiber of the insertion part are fixed at the other end of the light-guiding hose, and the electronic camera sensor and the light-guiding illumination optical fiber are connected to the electronic image processor and the cold light source respectively.

8. The free-direction guided visual guidewire device according to claim 1, characterized in that: The lens spacing of the miniature viewfinder objective lens group is accurately set according to the depth of field distance of the collected image through the thickness of the internal metal spacer.

9. The free-direction guided visual guidewire device according to claim 1, characterized in that: The overall outer diameter of the device is less than 0.9 mm, so as to meet the use requirements of entering ultra-fine tube lumens and narrow parts.

10. An application method of the free-direction guided visual wire mirror device according to any one of claims 1 to 9, characterized in that: include: During the examination of the fallopian tube cavity, the visual guidewire is inserted through the working channel of the hysteroscope, and the front free-directional guide end is manipulated to advance along the fallopian tube channel to the ovarian position at a propulsion speed not exceeding 0.5 mm / s; when assisting the duodenoscope in performing operations in the bile duct, the visual guidewire is inserted through the working channel of the duodenoscope, and the free-directional guide end is used to adjust the direction to enter the bile duct at a rotation speed not exceeding 1 mm / s without relying on radiation.

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