Split-type degradable fallopian tube stent and soft fallopian tube mirror for delivering the stent

Abstract

This invention discloses a split-type biodegradable fallopian tube stent and a flexible fallopian tube endoscope for delivering the stent. The stent includes a cervical probe, a flexible fallopian tube endoscope, and an imaging module. The cervical probe is adjustable from 0-90° via a universal joint. The lower end of the universal joint is connected to an external fixation stent via a ball-head universal joint structure. A connecting channel is located in the middle of the universal joint. The external fixation stent is a hollow tube structure and is fixedly installed. The flexible fallopian tube endoscope serves as the delivery channel and transmits signals to the imaging module via a wireless module for imaging. The flexible fallopian tube endoscope passes sequentially from bottom to top through the external fixation stent, the connecting channel, and the cervical probe before extending into the operating area within the uterine cavity. A magnetic navigation microcatheter is located at the end of the flexible fallopian tube endoscope, supporting external magnetic field navigation and positioning. This invention is convenient to operate, has high positioning accuracy, and is highly safe during operation.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a split-type biodegradable fallopian tube stent and a soft fallopian tube endoscope for delivering the stent, which is suitable for examination and treatment of fallopian tube blockage, intrauterine adhesions, endometrial polyps, etc. Background Technology

[0002] Traditional treatments for fallopian tube blockage rely on metal guidewires or single-material stents, which are highly invasive, have a re-adhesion rate greater than 30%, and whose degradation cycles do not match anatomical requirements. For example, US patent US10912567B2 lacks the ability to deliver fallopian tube stents. Existing fallopian tube endoscopes, such as the Olympus HYF-IT fallopian tube endoscope, cannot be adapted to operations on ultra-thin fallopian tubes due to diameter limitations, and have limited functionality.

[0003] Current treatments for fallopian tube blockage and fallopian tube endoscopy have the following drawbacks:

[0004] 1. Traumatic procedure: Traditional guidewire recanalization requires uterine cannulation, which can easily lead to endometrial damage, bleeding and postoperative adhesions.

[0005] 2. High re-adhesion rate after surgery: Metal stents require a second removal to form re-adhesion, and the degradation cycle of polymer stents does not match the repair cycle, such as PLA, which requires 2-3 years.

[0006] 3. Complex operation: Multi-component dispensing devices require multiple assembly steps, such as uterine tubes, connecting tubes, and syringes, which increases the risk of contamination and operation time.

[0007] 4. Limitations of traditional fallopian tube endoscopy:

[0008] (1) The structure limits the operating angle and cannot adapt to the complex anatomy of the fallopian tube;

[0009] (2) It has a single function and requires the use of multiple instruments, which increases the operation time and risk;

[0010] (3) The postoperative re-adhesion rate is high, and patients need repeated treatments. Summary of the Invention

[0011] To address the aforementioned problems in the prior art, this invention proposes a split-type biodegradable fallopian tube stent and a flexible fallopian tube endoscope for delivering the stent. By combining a flexible fallopian tube endoscope with specific materials, and outlining detailed steps and operating methods, this invention achieves multifunctional integration and anatomical adaptation, meeting the needs of various procedures.

[0012] The split-type biodegradable fallopian tube stent includes a stratigraphic stent, an isthmic stent, and an ampulla stent, which are connected in series by biodegradable sutures and arranged from top to bottom.

[0013] The interstitial scaffold is cylindrical with a diameter of 0.6±0.1 mm, coated with a sodium heparin anticoagulant layer, has a porosity of ≥90%, and a degradation cycle of 3.5-4.5 months.

[0014] Furthermore, the interstitial scaffold has a diameter of 0.6±0.1mm, and the surface anticoagulant layer is loaded using electrospinning technology with a fiber diameter of 100-200nm and a degradation cycle of 4 months.

[0015] Furthermore, the biodegradable suture is a polydioxanone suture with a degradation period of 3 months and a tensile strength greater than or equal to 5N.

[0016] Furthermore, the isthmus support has a helical spring structure with a mesh porosity of ≥80% and a degradation cycle of 5-7 months.

[0017] Furthermore, the spring structure of the isthmus support has a diameter of 1.0±0.1mm, an elastic modulus of 1.0±0.2GPa, and a degradation cycle of 6 months.

[0018] Furthermore, the ampulla support has a mesh-like porous structure with a mesh porosity of 85±5%, and the surface is coated with a hyaluronic acid lubricating layer by an impregnation-crosslinking method, with a degradation cycle of 7-9 months.

[0019] Furthermore, the diameter of the mesh structure of the ampulla support is 2.0±0.2mm, the thickness of the hyaluronic acid lubricating layer is 2±0.5um, the degree of crosslinking is greater than or equal to 80%, and the degradation cycle is 8 months.

[0020] The flexible fallopian tube endoscope for delivering split-type biodegradable fallopian tube stents needs to be delivered to the target segment of the fallopian tube, including the matching cervical probe, flexible fallopian tube endoscope, imaging module, and magnetic navigation delivery channel;

[0021] The flexible fallopian tube endoscope serves as the delivery channel, and signals are transmitted to the imaging module via a wireless module for imaging.

[0022] The flexible fallopian tube endoscope passes through the external fixation frame, the connecting tube, and the cervical probe from bottom to top before being inserted into the operating area inside the uterine cavity. The end of the flexible fallopian tube endoscope is equipped with a magnetic navigation microcatheter, and the tip of the magnetic navigation microcatheter is equipped with a neodymium iron boron magnet to support external magnetic field navigation and positioning.

[0023] Furthermore, the cervical probe is a hollow, downward-facing trumpet-shaped structure. The cervical probe is adjustable from 0 to 90 degrees via a universal joint. The lower end of the universal joint is connected to an external fixation bracket via a ball joint structure. A connecting pipe is provided in the middle of the universal joint. The external fixation bracket is a hollow tube structure and is fixedly installed.

[0024] The bending angle at the end of the soft fallopian tube endoscope is greater than or equal to 270 degrees, and the magnetic force at the tip of the magnetic navigation microcatheter is greater than or equal to 0.3T.

[0025] The soft fallopian tube endoscope is marked with positioning markers, and X-ray imaging rings are set every 1 mm on the surface of the endoscope. The X-ray imaging rings are made of platinum-iridium alloy, with a width of 0.1 mm and an imaging density of greater than or equal to 300 HU.

[0026] Furthermore, the outer wall of the upper end of the cervical probe is provided with at least two annular silicone sealing protrusions from top to bottom, with the diameter increasing gradually from top to bottom to adapt to different cervical canal diameters, and the Shore hardness is 30A.

[0027] The cervical probe is made of thermoplastic polyurethane with a hardness of 40 Shore A and is coated with a hydrophilic lubricating layer.

[0028] The imaging module uses fiber optic transmission with a fiber diameter of 0.2 mm, is equipped with a CMOS sensor, has a resolution of 4K, and an illumination brightness of ≥5000 Lux.

[0029] The soft fallopian tube endoscope has an outer diameter of less than or equal to 2.4 mm, integrates ultra-fine fiber optic 4K imaging, and is made of thermoplastic polyurethane with a hardness of 40 Shore A. The soft fallopian tube endoscope has an inner diameter of 1.8 mm and a delivery channel of 0.6 mm to 1.6 mm.

[0030] Compared with the prior art, the split-type biodegradable fallopian tube stent and the flexible fallopian tube endoscope for delivering the stent described in this application have the following advantages:

[0031] (1) During the 4-8 month degradation period of the split stent in this application, the re-adhesion rate of the fallopian tube is less than 5% after the split stent is installed, compared to about 30% for traditional surgery. Moreover, the outer surface of the split stent is coated with hyaluronic acid to maintain a moist environment in the fallopian tube, promote the transport of fertilized eggs, prevent ectopic pregnancy, and improve the conception rate.

[0032] (2) The degradation cycle of the split-type stent of this application is 4, 6 or 8 months, covering the repair needs of each segment of the fallopian tube. The degradation products are excreted through metabolism. The degradation products include lactic acid and glycolic acid, which are not toxic to the embryo. Animal experiments show that the pregnancy rate after the stent is degraded is not significantly different from that of the healthy control group. The embryo safety of this application is higher.

[0033] (3) The flexible design of the soft fallopian tube endoscope of the present invention: breaks through the limitations of diameter and curvature to realize non-invasive fallopian tube intervention; multi-functional integration: integrated operation of "imaging-treatment-stent implantation" to improve efficiency; materials and navigation technology: magnetic tip + shape memory alloy to solve the problem of locating complex lesions.

[0034] (4) This application sets a cervical probe and external fixation bracket at the external os of the cervix, which can quickly pass through the cervical canal, making it convenient for clinicians to operate the equipment with both hands. The postoperative bleeding rate is less than 1%, and the operation time is less than or equal to 15 minutes. Compared with the traditional guidewire procedure of 30-45 minutes, the efficiency is increased by 50%. There is no need for uterine cannulation and cervical traction. The pain score is less than or equal to 2 points, which is the standard for pain assessment using the visual analog scale.

[0035] (5) This application is suitable for patients with fallopian tube adhesions, blockages, malformations, hydrosalpinx, etc., and solves the problems that existing technologies cannot solve for fallopian tube malformations and hydrosalpinx. The integrated packaging design allows for single-scope completion of stent implantation, adhesion release, polyp removal, and hydrosalpinx aspiration. The operation time is less than or equal to 15 minutes, reducing the risk of intraoperative contamination and making it highly clinically applicable.

[0036] (6) Reduce patient pain and complications, shorten recovery period; improve the success rate of fallopian tube blockage treatment, such as interstitial stenosis and ampullary tortuosity blockage; expand application to multiple scenarios such as intrauterine adhesions and polyp removal, reduce equipment procurement costs, and have high clinical value. Attached Figure Description

[0037] The accompanying drawings, which form part of this application, are used to provide a further understanding of this application. The illustrative embodiments and descriptions of this application are used to explain this application and do not constitute an undue limitation of this application. In the drawings:

[0038] Figure 1 This is a schematic diagram of the cervical probe in the soft fallopian tube endoscope for delivering a split-type biodegradable fallopian tube stent as described in this application;

[0039] Figure 2 For this application Figure 1 Enlarged view of Part I;

[0040] Figure 3 This is a schematic diagram of the universal joint structure in the flexible fallopian tube endoscope for delivering a split-type biodegradable fallopian tube stent as described in this application;

[0041] Figure 4 This is a schematic diagram of the structure of the split-type biodegradable fallopian tube stent in the flexible fallopian tube endoscope described in this application;

[0042] Figure 5 For this application Figure 4 Enlarged view of part A;

[0043] Figure 6 For this application Figure 4 Enlarged view of part B;

[0044] Figure 7 This is a structural schematic diagram of the soft fallopian tube endoscope and related components of this application;

[0045] Figure 8 This is a schematic diagram of the structure used in this application for delivering laser optical fibers to treat endometrial polyps;

[0046] Figure 9 This is a schematic diagram of the structure used in this application for delivering micro-scissors to decompose intrauterine adhesions;

[0047] Figure 10 This is a schematic diagram of the structure of the negative pressure suction catheter used in this application for suctioning fluid from the fallopian tubes;

[0048] Explanation of reference numerals in the attached figures:

[0049] 1. Cervical probe; 11. Sealing ring A; 12. Sealing ring B; 13. Sealing ring C; 2. Universal joint; 21. Connecting tube; 3. External fixation bracket; 5. Split-type bracket; 51. Interstitial bracket; 52. Isthmus bracket; 53. Ampulla bracket; 54. Biodegradable suture; 6. Flexible fallopian tube endoscope; 61. Magnetic navigation microcatheter; 62. X-ray imaging ring; 7. Imaging module; 8. Wireless module; 201. Polyp base; 202. Laser fiber; 301. Scissors; 302. Adhesion tissue; 601. Aspiration catheter; 602. Hydrosalpinx cavity. Detailed Implementation

[0050] To make the objectives, technical solutions, and advantages of this application clearer, the following detailed description is provided in conjunction with specific embodiments and the accompanying drawings.

[0051] It should be noted that, unless otherwise defined, the technical or scientific terms used in the embodiments of this application should have the ordinary meaning understood by one of ordinary skill in the art to which this application pertains. The terms "first," "second," and similar terms used in the embodiments of this application do not indicate any order, quantity, or importance, but are merely used to distinguish different components. Terms such as "comprising" or "including" mean that the element or object preceding the word encompasses the elements or objects listed after the word and their equivalents, without excluding other elements or objects. Terms such as "connected" or "linked" are not limited to physical or mechanical connections, but can include electrical connections, whether direct or indirect. Terms such as "upper," "lower," "left," and "right" are only used to indicate relative positional relationships; when the absolute position of the described object changes, the relative positional relationship may also change accordingly.

[0052] like Figure 1-10As shown, the split-type flexible fallopian tube endoscope includes a cervical probe 1, a flexible fallopian tube endoscope 6, and an imaging module 7. The cervical probe 1 is a hollow, downward-facing trumpet-shaped structure. The cervical probe 1 is adjustable from 0-90° via a universal joint 2. The lower end of the universal joint 2 is connected to an external fixation bracket 3 via a ball-head universal joint 2 structure. Figure 3 As shown, the universal joint 2 has a connecting pipe 21 in the middle, and the external fixation bracket 3 is a hollow tube structure and is fixedly installed. After the external fixation bracket 3 is fixed outside the uterine cavity, it serves two purposes: first, to avoid the movement of the position from affecting the soft fallopian tube endoscope during the operation; and second, to play a firm guiding role after fixing, thereby improving the stability of the overall structure.

[0053] The soft fallopian tube endoscope 6 serves as the delivery channel and transmits signals to the imaging module 7 via the wireless module 8 for imaging. Preferably, the imaging module 7 uses an ultra-fine optical fiber with a diameter of 0.2 mm, is equipped with a CMOS sensor, has a resolution of 4K, and an illumination brightness of ≥5000 Lux.

[0054] The flexible fallopian tube endoscope 6 passes through the external fixator 3, the connecting tube 21, and the cervical probe 1 from bottom to top, and then extends into the operating area within the uterine cavity. Figure 7 As shown, the soft fallopian tube endoscope 6 is equipped with a magnetic navigation microcatheter 61 with a bending angle of ≥270 degrees. The tip of the magnetic navigation microcatheter 61 is equipped with a neodymium iron boron magnet with a magnetic force of ≥0.3T to support external magnetic field navigation and positioning. The soft fallopian tube endoscope 6 is marked for positioning. X-ray imaging rings 62 are provided every 1mm on the surface of the endoscope. The X-ray imaging rings 62 are made of platinum-iridium alloy, with a width of 0.1mm and a imaging density of ≥300HU.

[0055] Preferably, such as Figure 1 and Figure 2 As shown, at least two annular silicone sealing protrusions are arranged sequentially from top to bottom on the outer wall of the upper end of the cervical probe 1 to adapt to different cervical canal diameters; more preferably, the number of sealing protrusions is 3, with the diameters increasing from top to bottom, namely sealing ring A11, sealing ring B12 and sealing ring C13, with diameters of 3mm, 5mm and 7mm respectively from top to bottom, to meet the sealing requirements under different application conditions, and the Shore hardness of the cervical probe 1 is 30A; more preferably, the material of the cervical probe 1 is thermoplastic polyurethane with a hardness of 40 Shore A, and the entire surface is coated with a hydrophilic lubricating layer.

[0056] Preferably, the soft fallopian tube endoscope 6 has an outer diameter of less than or equal to 2.4 mm. Its small size minimizes any additional impact on the human body during application, thus providing better protection. It integrates ultra-fine fiber optic 4K imaging to ensure image quality. The material is thermoplastic polyurethane with a hardness of 40 Shore A. The inner diameter of the soft fallopian tube endoscope 6 is 1.8 mm, and the delivery tube is 0.6-1.6 mm, meeting the delivery needs in various application scenarios.

[0057] Preferably, the flexible fallopian tube endoscope 6 is used to push the split-type stent 5 to the target segment, and the split-type stent 5 is connected in series by biodegradable sutures 54, such as... Figure 4 As shown, the split stent 5 includes an interstitial stent 51, an isthmus stent 52, and an ampulla stent 53 arranged sequentially from top to bottom. The degradation cycle of the split stent 5 is adapted to the actual application environment. Currently, most cardiac stents do not require degradation. If degradation is required, a degradation cycle of 2-3 years or more must be guaranteed to prevent the formation of coronary vascular embolism. Alloy stents are often used. However, in the application environment of this device, a shorter degradation cycle is required, which is the opposite of the previous requirement of pursuing a longer degradation cycle. Current materials cannot be used as a reference. It is necessary to select materials with a shorter degradation cycle, suitable for the application environment of this application, and harmless to the human body and fetus. The materials and hardness selected in this application meet the application requirements and also comply with the degradation cycle requirements.

[0058] Preferably, the biodegradable suture 54 is a polydioxanone suture with a degradation cycle of 3 months and a tensile strength of 5N or more. By selecting a suitable material for the uterine cavity environment, the degradation cycle can be extended, thus shortening the treatment cycle.

[0059] The interstitial scaffold 51 is made of polylactic acid-glycolic acid copolymer, is cylindrical, has a diameter of 0.6±0.1 mm, and is coated with a sodium heparin anticoagulant layer that is loaded using electrospinning technology. Figure 5 This is a magnified image of the surface after electrospinning. The fiber diameter is 100-200 nm, the porosity is greater than or equal to 90%, and the degradation period is 4 months.

[0060] The isthmus scaffold 52 is made of polylactic acid-glycolic acid copolymer, polycaprolactone and 5% calcium carbonate nanoparticles. The polycaprolactone is PCL 10%wt, which has a helical spring structure with a diameter of 1.0±0.1mm, an elastic modulus of 1.0±0.2GPa, and a mesh porosity of ≥80%. The surface is coated with a chitosan-dexamethasone anti-inflammatory layer and a hyaluronic acid lubricating layer, and the degradation cycle is 6 months.

[0061] The ampullary scaffold 53 is made of polylactic acid-glycolic acid copolymer with a mesh-like porous structure, a diameter of 2.0±0.2mm, and a mesh porosity of 85±5%. The surface is coated with a hyaluronic acid lubricating layer by impregnation-crosslinking method. The hyaluronic acid lubricating layer is a crosslinking agent EDC / NHS with a coating thickness of 2±0.5um, a crosslinking degree of greater than or equal to 80%, and a degradation cycle of 8 months. The porosity setting of the ampullary scaffold 53 fully considers the needs of fertilized eggs to migrate back into the uterine cavity. In actual application, it can be used after a short treatment period.

[0062] The method of using a flexible fallopian tube endoscope for delivering a split-type biodegradable fallopian tube stent includes the following steps:

[0063] S1: The cervical probe 1 is inserted into the cervical canal non-invasively to adjust the natural curvature and anteroposterior and retroverted angles of the cervical canal, and is sealed to prevent leakage through the silicone sealing protrusion.

[0064] S2: The flexible fallopian tube endoscope 6 enters the uterine cavity through the fluid inlet, and 4K imaging is used to locate the working segment;

[0065] S3: The magnetic navigation microcatheter 61 pushes the delivery tool to the target position. The imaging module 7 is used to simultaneously display the situation inside the uterine cavity. The external magnetic field assists in adjusting the unfolding angle. During the actual operation, the doctor fixes the internal magnetic navigation microcatheter 61 with the external magnetic field according to the displayed situation and the needs of the operation.

[0066] Preferably, when the flexible fallopian tube endoscope 6 is used to place a stent, the flexible fallopian tube endoscope 6 locates the blocked segment, the magnetic navigation microcatheter pushes the split stent to the target position, and the external magnetic field assists in adjusting the unfolding angle; the suture and the split stent are degraded to complete the process;

[0067] like Figure 8 As shown, the soft fallopian tube endoscope 6 is used to deliver the micro scissors 301 for intrauterine adhesions, with a blade length of 1 mm and a shearing force greater than or equal to 0.5 N;

[0068] like Figure 9 As shown, the soft fallopian tube endoscope 6 is used to deliver the laser fiber 202 to the endometrial polyp, with a wavelength of 980nm and a power of less than or equal to 10W;

[0069] like Figure 10 As shown, the flexible fallopian tube endoscope 6 is used to insert a negative pressure aspiration catheter 601 for hydrosalpinx, with a negative pressure of less than or equal to 50 kPa and a catheter diameter of 0.5 mm. It extracts the hydrosalpinx from the hydrosalpinx cavity 602 and drains it out of the uterine cavity. This targeted aspiration replaces traditional non-surgical and surgical treatments, offering high precision, high extraction efficiency, short treatment cycle, and rapid results.

[0070] The parameters of this product are compared with those of other products on the market as follows.

[0071] 1. Product Name: Olympus HYF-IT Fallopian Tube Endoscope, Parameters: Outer diameter 3.5mm, rigid body, supports imaging and biopsy only.

[0072] Comparison: This invention features a 2.4mm soft endoscope structure, eliminating the need for cervical dilation, allowing for non-invasive and painless entry into the uterine cavity, resulting in higher safety. It also integrates treatment functions, such as laser and stent implantation, to meet the operational needs of various usage environments.

[0073] 2. Product Name: Storz27005K Fallopian Tube Endoscopy System; Parameters: Supports laser treatment, but requires an external instrument channel with a diameter greater than or equal to 4.0 mm.

[0074] Comparison: In this invention, the soft fallopian tube endoscope 6 uses 0.2mm ultra-fine optical fiber 4K imaging, with an inner diameter of 1.8mm and a delivery channel of 0.6-1.6mm. As an integrated working channel, doctors can operate the equipment while observing the imaging. Observation and equipment operation can be carried out simultaneously, which is convenient, fast, and ensures accuracy while improving work efficiency.

[0075] The following are specific examples of the application of this application.

[0076] Example 1: The treatment steps for interstitial blockage are as follows.

[0077] (1) Preoperative preparation: The patient is placed in the lithotomy position, and after disinfection, the bionic cervical probe head 1 is inserted.

[0078] (2) Imaging and localization: Interstitial blockage was confirmed by soft fallopian tube endoscopy 6,4K imaging, with the blockage length less than or equal to 2 mm.

[0079] (3) Stent implantation: The interstitial stent 51 is pushed to the blockage segment through the magnetic navigation microcatheter 61 in the working channel. The angle is finely adjusted by the external magnetic field, and the stent expands to fit the tube wall. The diameter of the interstitial stent 51 is no more than 0.6 mm.

[0080] (4) Postoperative management: oral antibiotics for 3 days, try to conceive 3 months after surgery, the stent degradation cycle is 4 months. As mentioned above, the split stent allows sperm and eggs to pass through.

[0081] Data supports the relevant experiments: 30 New Zealand rabbits were randomly divided into experimental and control groups. The New Zealand rabbits were female and weighed 2.5-3.8 kg. To ensure the reproducibility of the experiment, the experimental group was implanted with 51 interstitial stents, while the control group was implanted with traditional guidewires. The total number of experimental subjects was n=15.

[0082] Testing method: Patency was assessed by hysterosalpingography 4 months after the operation, and the natural conception rate was calculated.

[0083] Results: The conception rate of the New Zealand rabbits in the experimental group was 88% (13 / 15) 4 months after surgery, while that in the control group was 60% (9 / 15). The conception rate in the animal experiment was 88%, and the degradation residue was less than 3%.

[0084] Example 2: Blockage and adhesion in the isthmus.

[0085] The different steps in the operation process are as follows.

[0086] (1) Combined operation: After the fallopian tube endoscope enters the uterine cavity, the adhesion tissue 302 is first released by scissors.

[0087] (2) Stent implantation: Replace the tip of the magnetic navigation microcatheter 61, push the isthmus stent 52 to the isthmus blockage section. The diameter of the isthmus stent 52 is 1.0 mm. Verify the position with X-ray.

[0088] (3) Synchronous treatment: The hyaluronic acid coating on the stent surface is continuously released, inhibiting postoperative inflammation.

[0089] When using this device and following the above procedures, the re-adhesion rate is less than 5%, and the guidewire rate is greater than 30%; the pregnancy rate is 70% for natural pregnancy within one year after the procedure, which is significantly higher than the 45% of the traditional procedure.

[0090] Example 3: In the case of multiple blockages in the body of the pot, the routine steps are the same as above, and other operations are as follows.

[0091] (1) Separate implantation: The ampulla stent 53 with a diameter of 2.0 mm and the isthmus stent 52 with a diameter of 1.0 mm are pushed sequentially through the working channel of the fallopian tube endoscope and connected in series with biodegradable sutures.

[0092] (2) Dynamic adjustment: The magnetic head of the magnetic navigation microcatheter 61 is used in conjunction with an external magnetic field to adjust the unfolding angle of the split-type stent 5 in the curved ampulla.

[0093] (3) Postoperative assessment: The stent position was examined by ultrasound one month after the operation, and the recanalization rate was confirmed by angiography three months after the operation.

[0094] Example 4: Application of the flexible fallopian tube endoscopy with multiple procedures, and application of the equipment described in this application for the removal of endometrial polyps using laser fiber optics.

[0095] Case background: The patient, a 32-year-old female, presented with abnormal uterine bleeding. Ultrasound revealed a single polyp in the uterine cavity, with a diameter of 8 mm.

[0096] The operation steps are as follows.

[0097] 1. Preoperative preparation: The patient is placed in the lithotomy position, and routine disinfection and draping are performed without anesthesia.

[0098] The soft fallopian tube endoscope 6 is inserted non-invasively through the cervix with a 1-point probe, and leak is prevented by a silicone sealing protrusion.

[0099] 2. Imaging and localization: 4K ultra-high-definition imaging shows the polyp is located at the fundus of the uterus, with a base width of approximately 3mm. Figure 8 As shown.

[0100] 3. Laser resection: Through the working channel, i.e. the inner diameter of the soft fallopian tube endoscope 6 is 1.8mm, the delivery channel is 0.6-1.6mm, a 980nm laser fiber is introduced, the power is set to 8W, the spot diameter is 0.3mm, and the magnetic navigation microcatheter 61 is adjusted to the fiber tip to the polyp base 201, vaporizing the tissue layer by layer, with a total bleeding volume of less than 1mL.

[0101] 4. Postoperative management: Oral antibiotics for 3 days after surgery. Normal activities can be resumed 2 hours later. A follow-up fallopian tube endoscopy one month later showed no residual polyps and complete endometrial repair.

[0102] Success rate: complete polyp removal rate greater than or equal to 95%; complications: postoperative bleeding rate less than 1%, no cases of uterine perforation.

[0103] Example 5: Using the device and method of this application to release intrauterine adhesions with micro scissors 301.

[0104] Case background: The patient was a 28-year-old female who developed moderate intrauterine adhesions after an induced abortion, affecting the middle part of the uterine cavity.

[0105] The operation steps are as follows.

[0106] 1. Preoperative assessment: Fallopian tube endoscopy showed that the adhesion tissue 302 was dense, with an area of ​​about 2cm × 1cm, which obstructed the opening of the fallopian tube.

[0107] 2. Adhesion loosening: A micro scissor 301 with a blade length of 1mm and a shearing force of 0.8N is introduced through the working channel. The angle is adjusted to the edge of the adhesion using magnetic navigation. The fibrous adhesions are cut layer by layer, debris is removed, and the normal inner membrane is preserved. Figure 9 As shown.

[0108] 3. Combined treatment: After the adhesions are released, hyaluronic acid gel is injected through the perfusion cavity. The amount of hyaluronic acid gel is 5mL to prevent re-adhesion. A 52-inch isthmus stent is implanted for support and repair. The degradation period is 6 months.

[0109] 4. Postoperative follow-up: Hysterosalpingography at 3 months postoperatively showed normal uterine cavity morphology and patent fallopian tubes; natural conception occurred 6 months postoperatively, with a good pregnancy outcome.

[0110] Clinical data: Re-adhesion rate: less than 5%.

[0111] Pregnancy rate: The natural pregnancy rate within 1 year after surgery was 70%. The data is only available for the experimental group with a data set of n=30. In this application, n represents the total number of data sets, and the meaning is the same throughout the text.

[0112] Other data examples: A randomized controlled trial was conducted on 120 patients with fallopian tube adhesions. The experimental group was implanted with the split stent described in this application, while the control group used the traditional guidewire technique. n=60.

[0113] Experimental results: The re-adhesion rate in the experimental group 6 months after surgery was 4.8%, which was significantly lower than that in the control group (28.3%), demonstrating the clinical effectiveness of the split stent 5 of this invention and confirming that the re-adhesion rate was less than 5%.

[0114] Example 6: Application of the equipment and method of this application for suctioning hydrosalpinx using a negative pressure suction tube.

[0115] Case background: The patient is a 35-year-old female with hydrosalpinx in the left fallopian tube, 3 cm in diameter, and has been infertile for 2 years.

[0116] The operation steps are as follows.

[0117] 1. Non-invasive intervention: The soft fallopian tube endoscope 6 is inserted into the uterine cavity through the cervix 1. 4K imaging confirms hydrosalpinx on the left side and fimbrial occlusion.

[0118] 2. Water aspiration: A 0.5mm diameter negative pressure suction tube is introduced through the working channel, with the tip inserted into the water cavity. A negative pressure of 40kPa is set, and approximately 5mL of turbid fluid is aspirated. Simultaneously, antibiotic flushing solution is injected. Figure 10 As shown.

[0119] 3. Combined stent implantation: After aspiration, a stent 53 with a porosity of 85% is implanted in the ampulla through the same channel to promote the recovery of ciliary function.

[0120] 4. Postoperative assessment: One week after the operation, ultrasound showed that the fluid accumulation had disappeared, and three months later, hysterosalpingography showed that the fallopian tubes were patent.

[0121] Six months after the surgery, she successfully became pregnant through in-vitro fertilization.

[0122] Clinical data: Aspiration efficiency: fluid clearance rate greater than or equal to 90%, operation time less than or equal to 10 minutes.

[0123] Recurrence rate: The recurrence rate of fluid accumulation 1 year after surgery is less than 10%, while that of traditional puncture surgery is greater than 40%.

[0124] Using the device of this application and following the operating method of this application, polyp removal, adhesion release, fluid aspiration and stent implantation can be completed with a single endoscope in a non-invasive and efficient manner, avoiding the need to switch between multiple instruments.

[0125] Precise and safe: Magnetic navigation and ultra-thin design reduce the risk of puncture, with an incidence rate of less than 0.1%.

[0126] Fertility friendly: The postoperative recovery period is shortened by 50%, significantly improving the natural pregnancy rate.

[0127] This patent combines a soft fallopian tube endoscope with specially designed materials, specific steps, and operating methods to achieve multifunctional integration and anatomical adaptation, meeting the needs of various procedures.

[0128] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention, and they should all be covered within the scope of the claims and specification of the present invention.

[0129] The embodiments of this application are intended to cover all such substitutions, modifications, and variations that fall within the broad scope of the appended claims. Therefore, any omissions, modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the embodiments of this application should be included within the protection scope of this application.

Claims

1. A split-type biodegradable fallopian tube stent, characterized in that: It includes an interstitial scaffold, an isthmus scaffold, and an ampulla scaffold, which are connected in series from top to bottom by biodegradable sutures; the interstitial scaffold is cylindrical with a diameter of 0.6±0.1mm, coated with a sodium heparin anticoagulant layer, with a porosity of greater than or equal to 90%, and a degradation cycle of 3.5-4.5 months; The biodegradable suture is a polydioxanone suture with a degradation period of 3 months and a tensile strength of 5N or greater. The isthmus support has a spiral spring structure with a mesh porosity of ≥80% and a degradation cycle of 5-7 months. The ampulla support has a mesh-like porous structure with a mesh porosity of 85±5%. The surface is coated with a hyaluronic acid lubricating layer by an impregnation-crosslinking method, and the degradation cycle is 7-9 months.

2. The split-type biodegradable fallopian tube stent according to claim 1, characterized in that: The interstitial scaffold has a diameter of 0.6±0.1mm, and the surface anticoagulant layer is loaded by electrospinning technology with a fiber diameter of 100-200nm and a degradation cycle of 4 months.

3. The split-type biodegradable fallopian tube stent according to claim 1, characterized in that: The spring structure of the isthmus support has a diameter of 1.0±0.1mm, an elastic modulus of 1.0±0.2GPa, and a degradation period of 6 months.

4. The split-type biodegradable fallopian tube stent according to claim 1, characterized in that: The mesh structure of the ampulla support has a diameter of 2.0±0.2mm, a hyaluronic acid lubricating layer thickness of 2±0.5um, a cross-linking degree of greater than or equal to 80%, and a degradation cycle of 8 months.

5. A flexible fallopian tube endoscope for delivering a split-type biodegradable fallopian tube stent, characterized in that: The fallopian tube stent as described in any one of claims 1-4 is used to deliver the split-type biodegradable fallopian tube stent to the target segment of the fallopian tube, comprising a cervical probe, a flexible fallopian tube endoscope, and an imaging module; the flexible fallopian tube endoscope serves as the delivery conduit and transmits signals to the imaging module via a wireless module for imaging; the flexible fallopian tube endoscope passes through the external fixation stent, the connecting conduit, and the cervical probe sequentially from bottom to top and then extends into the operating area within the uterine cavity; the end of the flexible fallopian tube endoscope is provided with a magnetic navigation microcatheter, and the tip of the magnetic navigation microcatheter is provided with a neodymium iron boron magnet to support external magnetic field navigation and positioning; The cervical probe is a hollow, downward-facing, trumpet-shaped structure. The cervical probe is adjustable from 0-90° via a universal joint. The lower end of the universal joint is connected to an external fixation bracket via a ball-joint structure. A connecting tube is located in the middle of the universal joint. The external fixation bracket is a hollow tube structure and is fixedly installed. The bending angle of the end of the flexible fallopian tube end is greater than or equal to 270 degrees, and the magnetic force at the tip of the magnetic navigation microcatheter is greater than or equal to 0.3T. The flexible fallopian tube end is marked with positioning markers, and X-ray imaging rings are provided every 1mm on the surface of the endoscope. These X-ray imaging rings are made of platinum-iridium alloy, 0.1mm wide, and have a imaging density greater than or equal to 300HU.

6. The flexible fallopian tube endoscope for delivering a split-type biodegradable fallopian tube stent according to claim 5, characterized in that: The outer wall of the upper end of the cervical probe is provided with at least two annular silicone sealing protrusions arranged sequentially from top to bottom, with the diameter gradually increasing from top to bottom to adapt to different cervical canal diameters, and the Shore A hardness is 30A; the cervical probe is made of thermoplastic polyurethane with a hardness of 40 Shore A, and the surface is coated with a hydrophilic lubricating layer; the imaging module uses fiber optic transmission with a fiber diameter of 0.2mm, is equipped with a CMOS sensor, has a resolution of 4K, and an illumination brightness greater than or equal to 5000 Lux; the flexible fallopian tube endoscope has an outer diameter of less than or equal to 2.4mm, integrates ultra-fine fiber optic 4K imaging, is made of thermoplastic polyurethane with a hardness of 40 Shore A, and has an inner diameter of 1.8mm and a delivery channel of 0.6-1.6mm.

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