Split type degradable fallopian tube stent and soft fallopian tube lens for conveying same

Abstract

The split type degradable fallopian tube support comprises a cervix uteri probing head, the soft fallopian tube lens and an imaging module which are arranged in a matched mode, the curvature of the cervix uteri probing head is adjusted by 0-90 degrees through a universal joint, and the lower end of the universal joint is connected with an external fixing support through a ball universal joint structure; a communicating pipeline is arranged in the middle of the universal joint, and the outer fixing support is of a hollow pipe structure and is fixedly arranged. The soft fallopian tube lens serves as a conveying pipeline, and signal transmission is achieved through the wireless module and the imaging module so that imaging can be achieved. The soft fallopian tube lens sequentially penetrates through the outer fixing support, the communicating pipeline and the cervix probing head from bottom to top and then extends into an operation area in a uterine cavity, and a magnetic navigation micro catheter is arranged at the tail end of the soft fallopian tube lens and supports external magnetic field navigation and positioning. The device is convenient to operate, high in positioning precision and high in safety in the operation process.

Description

Technical Field

[0001] The present invention relates to the field of medical device technology, specifically to a split-type degradable fallopian tube stent and a soft fallopian tube mirror for delivering the stent, which is suitable for examination and treatment of fallopian tube obstruction, uterine cavity adhesions, endometrial polyps and the like. Background Art

[0002] Traditional treatments for fallopian tube obstruction rely on metal guidewires or single-material stents, which are highly invasive, have re-adhesion rates exceeding 30%, and a degradation cycle that doesn't align with anatomical requirements. For example, U.S. Patent No. 10912567B2 lacks the ability to deliver fallopian tube stents. Existing fallopian tube scopes, such as the Olympus HYF-IT fallopian tube scope, are limited in diameter and cannot accommodate ultra-thin fallopian tubes, and their functionality is limited.

[0003] The existing treatment of fallopian tube obstruction and fallopian tube endoscopy have the following pain points: 1. Traumatic operation: Traditional guidewire dredging requires uterine intubation, which can easily lead to endometrial damage, bleeding and postoperative adhesions.

[0004] 2. High postoperative re-adhesion rate: Metal stents need to be removed twice to form re-adhesion, and the degradation cycle of polymer stents does not match the repair cycle, such as PLA, which takes 2-3 years.

[0005] 3. Complex operation: Multi-component sub-packaging liquid-transmitting devices need to be assembled multiple times, such as intrauterine tubes, connecting tubes, and syringes, which increases the risk of contamination and operation time.

[0006] 4. Limitations of traditional fallopian tube endoscopy: (1) The structure limits the operating angle and cannot adapt to the complex anatomy of the fallopian tube; (2) Single function, requiring multiple instruments to cooperate, increasing surgical time and risk; (3) The re-adhesion rate after surgery is high, and patients need repeated treatment. Summary of the Invention

[0007] In order to solve the above-mentioned problems existing in the prior art, the present invention proposes a split degradable fallopian tube stent and a soft fallopian tube mirror for delivering the stent. In response to the technical problems existing in the background technology, by setting a soft fallopian tube mirror, coordinating with set materials, and setting specific steps and operating methods, the three are combined innovatively to achieve multifunctional integration and anatomical adaptation to meet the needs of various operations.

[0008] The split degradable fallopian tube stent includes an interstitial stent, an isthmus stent and an ampulla stent which are connected in series by degradable sutures and arranged in sequence from top to bottom; The interstitial stent is cylindrical, with a diameter of 0.6±0.1 mm, a surface coated with a sodium heparin anticoagulant layer, a porosity greater than or equal to 90%, and a degradation period of 3.5-4.5 months.

[0009] Furthermore, the diameter of the interstitial scaffold is 0.6±0.1 mm, the surface anticoagulant layer is loaded by electrospinning technology, the fiber diameter is 100-200 nm, and the degradation period is 4 months.

[0010] Furthermore, the degradable suture is a polydioxanone suture with a degradation period of 3 months and a tensile strength of greater than or equal to 5N.

[0011] Furthermore, the isthmus stent has a coil spring structure, a mesh porosity greater than or equal to 80%, and a degradation period of 5-7 months.

[0012] Furthermore, the spring structure of the isthmus stent has a diameter of 1.0±0.1 mm, an elastic modulus of 1.0±0.2 GPa, and a degradation period of 6 months.

[0013] Furthermore, the ampulla stent has a grid-like pore structure with a grid porosity of 85±5%. The surface is fixedly coated with a hyaluronic acid lubricating layer by an immersion-crosslinking method, and the degradation period is 7-9 months.

[0014] Furthermore, the grid structure diameter of the ampulla stent is 2.0±0.2 mm, the thickness of the hyaluronic acid lubricating layer is 2±0.5 um, the cross-linking degree is greater than or equal to 80%, and the degradation period is 8 months.

[0015] The soft fallopian tube scope for delivering the split degradable fallopian tube stent needs to be delivered to the target section of the fallopian tube, including the cervical probe, soft fallopian tube scope, imaging module and magnetic navigation delivery channel; The soft fallopian tube mirror serves as a delivery channel, and the wireless module and the imaging module are used to transmit signals for imaging; The soft fallopian tube mirror passes through the external fixation bracket, the connecting pipe and the cervical insertion head from bottom to top and then extends into the operation area in the uterine cavity. The end of the soft fallopian tube mirror is provided with a magnetic navigation microcatheter, and the head end of the magnetic navigation microcatheter is provided with a neodymium iron boron magnet to support external magnetic field navigation positioning.

[0016] Furthermore, the cervical probe is a trumpet-shaped structure with a hollow interior and a downward opening. The cervical probe is adjusted to a curvature of 0-90° by a universal joint. The lower end of the universal joint is connected to the external fixing bracket via a ball joint structure. A connecting pipe is provided in the middle of the universal joint. The external fixing bracket is a hollow tube structure and is fixedly arranged. The bending angle of the end of the soft fallopian tube mirror is greater than or equal to 270 degrees, and the magnetic force of the magnetic navigation microcatheter head end is greater than or equal to 0.3T; The soft fallopian tube mirror is positioned and marked, and an X-ray developing ring is set every 1 mm on the surface of the mirror body. The X-ray developing ring is made of platinum-iridium alloy, has a width of 0.1 mm, and a developing density greater than or equal to 300HU.

[0017] 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, the diameter of which increases gradually from top to bottom to adapt to different cervical canal diameters, and the Shore hardness is 30A; The material of the cervical probe is thermoplastic polyurethane with a hardness of 40 Shore A and a hydrophilic lubricating layer coated on the surface; The imaging module uses optical fiber transmission, the optical fiber diameter is 0.2mm, and is equipped with a CMOS sensor with a resolution of 4K and an illumination brightness greater than or equal to 5000Lux; The outer diameter of the soft fallopian tube mirror is less than or equal to 2.4 mm, and it integrates ultra-fine optical fiber 4K imaging. The material is thermoplastic polyurethane with a hardness of 40 Shore A. The inner diameter of the soft fallopian tube mirror is 1.8 mm, and the delivery channel is 0.6 mm-1.6 mm.

[0018] Compared with the prior art, the split degradable fallopian tube stent and the soft fallopian tube scope for delivering the stent described in this application have the following beneficial effects: (1) During the 4-8 month degradation period of the split stent in this application, the fallopian tube re-adhesion rate is less than 5% after the split stent is installed, while the traditional surgery is about 30%. In addition, 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 pregnancy rate.

[0019] (2) The degradation cycle of the split stent of the present application is 4, 6 or 8 months, covering the repair needs of various sections of the fallopian tube. The degradation products are excreted through metabolism. The degradation products include lactic acid and glycolic acid, which are non-embryotoxic. 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 the present application is higher.

[0020] (3) The flexible design of the soft fallopian tube mirror of the present invention: breaks through the diameter and bending limitations to achieve non-invasive fallopian tube intervention; multifunctional integration: "imaging-treatment-stent implantation" integrated operation to improve efficiency; material and navigation technology: magnetic head + shape memory alloy to solve the problem of complex lesion positioning.

[0021] (4) This application sets a cervical probe and an external fixation bracket at the external os of the cervix, which can quickly pass through the cervical canal and facilitate the clinician 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, which is 50% more efficient than the 30-45 minutes of the traditional guide wire technique. There is no need for intrauterine catheterization and cervical traction. The pain score is less than or equal to 2 points, and the visual analog scale is used as the standard for pain assessment.

[0022] (5) This application is suitable for patients with fallopian tube adhesion, blockage, deformity, hydrosalpinx, etc., and solves the problems of clinical fallopian tube deformity and hydrosalpinx that cannot be solved by existing technologies. It has an integrated packaging design and can complete stent implantation, adhesion lysis, polypectomy, and hydrosalpinx aspiration with a single mirror. The operation time is less than or equal to 15 minutes, which reduces the risk of intraoperative contamination and has high clinical applicability.

[0023] (6) Reduce patient pain and complications, shorten the recovery period; improve the success rate of treatment for fallopian tube obstruction, such as interstitial stenosis and ampulla curvature obstruction; expand application to multiple scenarios such as intrauterine adhesions and polypectomy, reduce equipment procurement costs, and have high clinical value. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The accompanying drawings, which constitute part of this application, are intended to provide a further understanding of this application. The exemplary embodiments and descriptions of this application are intended to explain this application and do not constitute an improper limitation on this application. In the accompanying drawings: Figure 1 This is a schematic structural diagram of the cervical probe head in the soft fallopian tube scope for delivering the split-type degradable fallopian tube stent described in this application; Figure 2 For this application Figure 1 A magnified view of part I; Figure 3 This is a schematic diagram of the structure of the universal joint in the soft fallopian tube mirror for delivering the split-type degradable fallopian tube stent described in this application; Figure 4 This is a schematic structural diagram of a split stent in a soft fallopian tube scope for delivering a split degradable fallopian tube stent as described in the present application; Figure 5 For this application Figure 4 A magnified view of part A; Figure 6 For this application Figure 4 A magnified view of part B; Figure 7 This is a schematic diagram of the structure of the soft fallopian tube mirror and related parts of this application; Figure 8 This is a schematic diagram of the structure of the present application for delivering laser optical fiber to treat endometrial polyps; Figure 9 This is a schematic diagram of the structure of the micro scissors used in this application to decompose intrauterine adhesions; Figure 10 This is a schematic diagram of the structure of the negative pressure suction catheter used in this application to aspirate hydrosalpinx; Description of reference numerals: 1. Cervical probe; 11. Sealing ring A; 12. Sealing ring B; 13. Sealing ring C; 2. Universal joint; 21. Connecting pipe; 3. External fixator; 5. Split stent; 51. Interstitial stent; 52. Isthmus stent; 53. Ampulla stent; 54. Degradable suture; 6. Soft fallopian tube mirror; 61. Magnetic navigation microcatheter; 62. X-ray development ring; 7. Imaging module; 8. Wireless module; 201. Polyp base; 202. Laser fiber; 301. Scissors; 302. Adhesion tissue; 601. Suction catheter; 602. Hydrosalpinx cavity. DETAILED DESCRIPTION

[0025] In order to make the objectives, technical solutions and advantages of this application more clear, this application is further described in detail below in combination with specific embodiments and with reference to the accompanying drawings.

[0026] It should be noted that, unless otherwise defined, the technical terms or scientific terms used in the embodiments of the present application should have the usual meanings understood by people with ordinary skills in the field to which this application belongs. The "first", "second" and similar words used in the embodiments of the present application do not indicate any order, quantity or importance, but are only used to distinguish different components. "Include" or "comprise" and similar words mean that the elements or objects appearing before the word cover the elements or objects listed after the word and their equivalents, without excluding other elements or objects. "Connect" or "connected" and similar words are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. "Up", "down", "left", "right" and the like 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.

[0027] like Figure 1-10 As shown, the split-type soft fallopian tube mirror device includes a cervical probe head 1, a soft fallopian tube mirror 6 and an imaging module 7. The cervical probe head 1 is a trumpet-shaped structure with a hollow interior and an opening downward. The cervical probe head 1 can be adjusted to a curvature of 0-90 degrees through a universal joint 2. The lower end of the universal joint 2 is connected to an external fixing bracket 3 through a ball head universal joint 2 structure. Figure 3 As shown, a connecting pipe 21 is provided in the middle of the universal joint 2, and the external fixing bracket 3 is a hollow tube structure and is fixedly arranged. After the external fixing bracket 3 is fixed outside the uterine cavity, it can prevent the position movement from affecting the soft fallopian tube mirror during operation, and it can also play a firm guiding role after being fixed, thereby improving the stability of the overall structure. The soft fallopian tube mirror 6 serves as a delivery channel, and realizes signal transmission with the imaging module 7 through the wireless module 8 for imaging. Preferably, the imaging module 7 adopts an ultra-fine optical fiber with a diameter of 0.2 mm, a CMOS sensor with a resolution of 4K, and an illumination brightness greater than or equal to 5000 Lux; The soft fallopian tube mirror 6 passes through the external fixing bracket 3, the connecting pipe 21 and the cervical probe 1 from bottom to top and then extends into the operation area in the uterine cavity. Figure 7 As shown, a magnetic navigation microcatheter 61 is provided at the end of the soft fallopian tube scope 6, with a bending angle greater than or equal to 270 degrees. A neodymium iron boron magnet is provided at the head end of the magnetic navigation microcatheter 61, with a magnetic force greater than or equal to 0.3T, which supports external magnetic field navigation positioning. The soft fallopian tube scope 6 is positioned and marked. An X-ray development ring 62 is provided every 1 mm on the surface of the scope. The X-ray development ring 62 is made of platinum-iridium alloy, has a width of 0.1 mm, and a development density greater than or equal to 300HU.

[0028] Preferably, if Figure 1 and Figure 2 As shown, at least two annular silicone sealing protrusions are provided on the outer wall of the upper end of the cervical probe 1 from top to bottom to adapt to different cervical canal diameters; more preferably, the number of sealing protrusions is 3, and the diameters increase gradually from top to bottom, namely sealing ring A11, sealing ring B12 and sealing ring C13, and the diameters are 3mm, 5mm and 7mm from top to bottom respectively, to meet the sealing requirements in different application situations, 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 40ShoreA, and the entire surface is coated with a hydrophilic lubricating layer.

[0029] Preferably, the outer diameter of the soft fallopian tube mirror 6 is less than or equal to 2.4 mm, and the specifications are small. It tries not to cause additional impact on the human body during use, and plays a better protective role on the human body. It integrates ultra-fine optical fiber 4K imaging to ensure the quality of imaging. The material is thermoplastic polyurethane with a hardness of 40ShoreA. The inner diameter of the soft fallopian tube mirror 6 is 1.8 mm, and the delivery pipe is 0.6-1.6 mm, which meets the delivery needs in various application situations.

[0030] Preferably, the soft fallopian tube mirror 6 is used to push the split stent 5 to the target section, and the split stent 5 is connected in series through a degradable suture 54, such as Figure 4As shown, the split stent 5 includes an interstitial stent 51, an isthmus stent 52 and an ampulla stent 53 arranged in sequence from top to bottom. The degradation cycle of the split stent 5 is adapted according to the actual environment of the application. At present, most heart stents do not need to be degraded. If degradation is required, the degradation cycle must be guaranteed to be more than 2-3 years. To ensure a longer degradation cycle and prevent the formation of cardiovascular embolism, alloy stents are mostly used. However, in the application environment of this device, a shorter degradation cycle is required, which is contrary to the previous requirement of pursuing a longer degradation cycle. The current materials cannot be used as a reference. It is necessary to select materials with a shorter degradation cycle, which are suitable for the use environment of this application and are harmless to the human body and fetus. The materials and hardness selected in this application meet the needs of the application and meet the requirements of the degradation cycle.

[0031] Preferably, the degradable suture 54 is a polydioxanone suture with a degradation period of 3 months and a tensile strength of 5N or greater. Suitable materials are selected according to the environment of the uterine cavity to complete the extension of the degradation period and shorten the treatment period. The interstitial stent 51 is made of polylactic acid-glycolic acid copolymer, cylindrical in shape, with a diameter of 0.6±0.1 mm, and coated with a sodium heparin anticoagulant layer through electrospinning technology. Figure 5 This is an enlarged view of the surface after electrospinning. The fiber diameter is 100-200nm, the porosity is greater than or equal to 90%, and the degradation period is 4 months. The isthmus stent 52 is made of a composite of polylactic-co-glycolic acid, polycaprolactone, and 5% calcium carbonate nanoparticles. The polycaprolactone is 10% by weight PCL. It has a coil spring structure, a diameter of 1.0±0.1 mm, an elastic modulus of 1.0±0.2 GPa, a mesh porosity greater than or equal to 80%, and is coated with a chitosan-dexamethasone anti-inflammatory layer and a hyaluronic acid lubricating layer. It has a degradation period of 6 months. The ampulla stent 53 is made of polylactic acid-glycolic acid copolymer with a grid-like pore structure, with a diameter of 2.0±0.2mm and a grid porosity of 85±5%. The surface is fixedly coated with a hyaluronic acid lubricating layer by an immersion-crosslinking method. The hyaluronic acid lubricating layer is a cross-linking agent EDC / NHS, with a coating thickness of 2±0.5um, a cross-linking degree greater than or equal to 80%, and a degradation period of 8 months. The porosity setting of the ampulla stent 53 fully considers the need for the fertilized egg to migrate back to the uterine cavity. In actual application, it can be cured after a short period of treatment.

[0032] The method for using a soft fallopian tube mirror for delivering a split degradable fallopian tube stent comprises the following steps: S1: The cervical probe 1 is non-invasively inserted into the cervical canal, adjusting the natural curvature of the cervical canal and the anteversion and posterior tilt angles, and sealing with a silicone seal to prevent leakage; S2: The soft fallopian tube scope 6 enters the uterine cavity through the fluid channel, and 4K imaging locates the working section; S3: The magnetic navigation microcatheter 61 pushes the transported tool to the target position, and the imaging module 7 is used to synchronously display the situation inside the uterine cavity. The external magnetic field assists in adjusting the deployment angle. During the actual operation, the doctor fixes the internal magnetic navigation microcatheter 61 through the external magnetic field according to the displayed situation and the needs of the operation.

[0033] Preferably, when the soft fallopian tube scope 6 is used to place the stent, the soft fallopian tube scope 6 locates the blocked section, the magnetic navigation microcatheter pushes the split stent to the target position, and the external magnetic field assists in adjusting the deployment angle; the suture and the split stent are degraded and the procedure is completed; like Figure 8 As shown, the soft fallopian tube mirror 6 is used to deliver 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; like Figure 9 As shown, the soft fallopian tube mirror 6 is used to deliver the endometrial polyp laser fiber 202, with a wavelength of 980nm and a power less than or equal to 10W; like Figure 10 As shown, the soft fallopian tube mirror 6 is used to deliver the hydrosalpinx negative pressure suction catheter 601, with a negative pressure of less than or equal to 50 kPa and a catheter diameter of 0.5 mm. The hydrosalpinx cavity 602 is used to extract the accumulated water and discharge it out of the uterine cavity. The targeted suction replaces the traditional non-surgical and surgical treatments with high precision, high extraction efficiency, short treatment cycle and quick effect.

[0034] The following is a parameter comparison of this product with market products.

[0035] 1. Product name: Olympus HYF-IT fallopian tube endoscope, parameters: outer diameter 3.5mm, hard endoscope, supports imaging and biopsy only.

[0036] Comparison points: The present invention has a 2.4mm soft endoscope structure, does not require cervical dilation, and can enter the uterine cavity non-invasively and painlessly, which is safer. It also integrates treatment functions such as laser and stent implantation to meet the operational requirements of various different usage environments.

[0037] 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.

[0038] Comparison point: In the present invention, the soft fallopian tube mirror 6 adopts 0.2mm ultra-fine optical fiber 4K imaging, has an inner diameter of 1.8mm, and a delivery pipe of 0.6-1.6mm. As an integrated working channel, the doctor can operate the equipment while observing the imaging. Observation and equipment operation are carried out simultaneously, which is convenient and fast, ensuring accuracy while improving work efficiency.

[0039] The following are specific examples of the application.

[0040] Example 1: The steps for treating interstitial obstruction are as follows.

[0041] (1) Preoperative preparation: The patient takes the lithotomy position, and after disinfection, the bionic cervical probe 1 is inserted.

[0042] (2) Imaging positioning: Soft fallopian tube endoscope 6, 4K imaging confirms interstitial blockage, and the blockage length is less than or equal to 2mm.

[0043] (3) Stent implantation: The interstitial stent 51 is pushed to the blocked section through the working channel magnetic navigation microcatheter 61. The angle is fine-tuned by the external magnetic field, and the stent self-expands to fit the tube wall. The diameter of the interstitial stent 51 is no more than 0.6 mm.

[0044] (4) Postoperative management: Oral antibiotics for 3 days, pregnancy preparation 3 months after surgery, stent degradation period 4 months. As mentioned in the above description, the split stent allows sperm and eggs to pass through.

[0045] Data support related experiments: 30 New Zealand rabbits were randomly divided into an experimental group and a control group. The New Zealand rabbits were female and weighed 2.5-3.8 kg to ensure experimental repeatability. The experimental group was implanted with interstitial stent 51, and the control group used traditional guidewire surgery. The total number of experiments was n=15.

[0046] Examination method: Four months after surgery, hysterosalpingography was used to assess patency and calculate the natural pregnancy rate.

[0047] Results: The pregnancy rate of New Zealand rabbits in the experimental group was 88%, i.e. 13 / 15, 4 months after surgery, while that in the control group was 60%, i.e. 9 / 15. The pregnancy rate in animal experiments was 88%, and the degradation residue was less than 3%.

[0048] Example 2: Isthmus obstruction combined with adhesion.

[0049] The different steps in the operation process are as follows.

[0050] (1) Combined operation: After the fallopian tube endoscope enters the uterine cavity, the adhesion tissue is first loosened with scissors 302.

[0051] (2) Stent implantation: Replace the tip of the magnetic navigation microcatheter 61 and push the isthmus stent 52 to the blocked section of the isthmus. The diameter of the isthmus stent 52 is 1.0 mm. X-ray verification of the position is performed.

[0052] (3) Concurrent treatment: The hyaluronic acid coating on the stent surface is continuously released to inhibit postoperative inflammation.

[0053] Using this device and following the above methods, the re-adhesion rate is less than 5%, while the guidewire procedure is greater than 30%. The pregnancy rate is 70% within 1 year after surgery, which is significantly higher than the 45% of the traditional procedure.

[0054] Example 3: In the case of multiple blockages in the ampulla, the conventional steps are the same as above, and the other operations are as follows.

[0055] (1) Separate implantation: The ampulla stent 53 (2.0 mm in diameter) and the isthmus stent 52 (1.0 mm in diameter) are sequentially pushed through the working channel of the fallopian tube mirror and connected in series with degradable sutures.

[0056] (2) Dynamic adjustment: The magnetic head of the magnetic navigation microcatheter 61 cooperates with the external magnetic field to adjust the deployment angle of the split stent 5 in the curved ampulla.

[0057] (3) Postoperative evaluation: Ultrasound examination of stent position was performed 1 month after surgery, and angiography was performed 3 months after surgery to confirm the recanalization rate.

[0058] Example 4: The soft fallopian tube mirror is used in multiple surgical procedures, and the device of this application is used in the case of laser fiber removal of endometrial polyps.

[0059] Case background: The patient, a 32-year-old female, came to the hospital for abnormal uterine bleeding. Ultrasound showed a single polyp in the uterine cavity with a diameter of 8 mm.

[0060] The steps are as follows.

[0061] 1. Preoperative preparation: The patient takes the lithotomy position, and routine disinfection and draping are performed. No anesthesia is required.

[0062] The soft fallopian tube mirror 6 is inserted into the head 1 through the cervix without invasive insertion and is leak-proof by the setting of the silicone sealing protrusion.

[0063] 2. Imaging positioning: 4K ultra-clear imaging shows that the polyp is located at the fundus of the uterus, with a base width of about 3mm. Figure 8 shown.

[0064] 3. Laser resection: Through the working channel, i.e., the inner diameter of the soft fallopian tube mirror 6 is 1.8mm, and 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 used to adjust the fiber tip to the polyp base 201, vaporizing the tissue layer by layer. The total bleeding volume is less than 1mL.

[0065] 4. Postoperative management: Oral antibiotics were administered for 3 days, and normal activities were resumed 2 hours later. A follow-up fallopian tube endoscopy was performed 1 month later, and no polyps were found and the endometrium was fully repaired.

[0066] Success rate: Complete polyp removal rate is greater than or equal to 95%; Complications: Postoperative bleeding rate is less than 1%, and there are no cases of uterine perforation.

[0067] Example 5: Micro scissors 301 are used to release intrauterine adhesions using the device and method of the present application.

[0068] Case background: The patient, a 28-year-old female, developed moderate intrauterine adhesions secondary to artificial abortion, involving the middle part of the uterine cavity.

[0069] The steps are as follows.

[0070] 1. Preoperative evaluation: Hysteroscopy showed dense adhesion tissue 302, approximately 2 cm × 1 cm in size, obscuring the fallopian tube opening.

[0071] 2. Adhesion release: Micro scissors 301 with a blade length of 1 mm and a shearing force of 0.8 N are introduced through the working channel. The angle is adjusted to the adhesion edge by magnetic navigation. The fibrous adhesion bands are sheared layer by layer to remove debris and preserve the normal endometrium. Figure 9 shown.

[0072] 3. Combined treatment: After adhesion lysis, 5 mL of hyaluronic acid gel is injected through the fluid passage cavity to prevent re-adhesion. A 52-meter isthmus stent is implanted to support the repair, and the degradation period is 6 months.

[0073] 4. Postoperative follow-up: Angiography 3 months after the operation showed that the uterine cavity morphology was normal and the fallopian tubes were unobstructed; natural conception occurred 6 months after the operation, and the pregnancy outcome was good.

[0074] Clinical data: Re-adhesion rate: less than 5%.

[0075] Pregnancy rate: The natural pregnancy rate within 1 year after surgery is 70%. The data is only for the case where the number of experimental group data n=30. In this application, n represents the total number of data groups and has the same meaning in the context.

[0076] 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, and the control group used traditional guidewire surgery, n=60.

[0077] Experimental results: The re-adhesion rate of the experimental group was 4.8% 6 months after surgery, which was significantly lower than 28.3% of the control group, proving the clinical effectiveness of the split stent 5 of the present invention and clearly showing that the re-adhesion rate was less than 5%.

[0078] Example 6: A negative pressure suction tube is used to aspirate hydrosalpinx using the device and method of the present application.

[0079] Case background: The patient, a 35-year-old female, had a hydrosalpinx on the left side, 3 cm in diameter, and had been infertile for 2 years.

[0080] The steps are as follows.

[0081] 1. Non-invasive intervention: The soft salpingoscope 6 is inserted through the cervix into the uterine cavity. 4K imaging confirms hydrosalpinx and fimbriae occlusion on the left fallopian tube.

[0082] 2. Aspiration of effusion: Introduce a 0.5mm diameter negative pressure suction tube through the working channel, place the tip into the effusion cavity, set the negative pressure to 40kPa, aspirate about 5mL of turbid effusion, and simultaneously inject antibiotic flushing solution, such as Figure 10 shown.

[0083] 3. Combined stent implantation: After aspiration, a 53-mm ampulla stent with a porosity of 85% is implanted through the same channel to promote the recovery of ciliary function.

[0084] 4. Postoperative evaluation: Ultrasound showed that the hydrops had disappeared 1 week after surgery, and hysterosalpingography showed patency 3 months later.

[0085] The patient successfully became pregnant through in vitro fertilization 6 months after the operation.

[0086] Clinical data: Suction efficiency: Fluid clearance rate is greater than or equal to 90%, and operation time is less than or equal to 10 minutes.

[0087] Recurrence rate: The recurrence rate of hydrops is less than 10% one year after surgery, while that of traditional puncture is greater than 40%.

[0088] By using the device of this application and following the operating method of this application, it is non-invasive and efficient, and polypectomy, adhesion lysis, water aspiration and stent implantation can be completed with a single mirror, avoiding the need to switch multiple instruments.

[0089] Precise and safe: Magnetic navigation + ultra-fine design reduces the risk of perforation, with an incidence rate of less than 0.1%.

[0090] Fertility-friendly: The postoperative recovery period is shortened by 50%, significantly improving the natural pregnancy rate.

[0091] This patent sets a soft fallopian tube mirror, matches it with set materials, and sets specific steps and operating methods. The three are combined innovatively to achieve multifunctional integration and anatomical adaptation to meet the needs of various operations.

[0092] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the above embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the above embodiments, or make equivalent replacements for some or all of the technical features therein. These modifications or replacements do not deviate the essence of the corresponding technical solutions from the scope of the technical solutions of the embodiments of the present invention, and they should all be included in the scope of the claims and description of the present invention.

[0093] The embodiments of the present 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 the present application should be included in the scope of protection of this application.

Claims

1. Split-type biodegradable fallopian tube stent, characterized by: It includes an interstitial stent, an isthmus stent and an ampulla stent which are connected in series and arranged from top to bottom in sequence through degradable sutures; The interstitial stent is cylindrical, with a diameter of 0.6±0.1 mm, a surface coated with a sodium heparin anticoagulant layer, a porosity greater than or equal to 90%, and a degradation period of 3.5-4.5 months.

2. The split-type degradable fallopian tube stent according to claim 1, characterized in that: The diameter of the interstitial scaffold is 0.6±0.1 mm, the surface anticoagulation layer is loaded by electrostatic spinning technology, the fiber diameter is 100-200 nm, and the degradation period is 4 months.

3. The split-type degradable fallopian tube stent according to claim 1, characterized in that: The degradable suture is a polydioxanone suture with a degradation period of 3 months and a tensile strength of greater than or equal to 5N.

4. The split-type degradable fallopian tube stent according to claim 1, characterized in that: The isthmus stent has a coil spring structure, a mesh porosity greater than or equal to 80%, and a degradation period of 5-7 months.

5. The split-type degradable fallopian tube stent according to claim 4, characterized in that: The spring structure of the isthmus stent has a diameter of 1.0±0.1 mm, an elastic modulus of 1.0±0.2 GPa, and a degradation period of 6 months.

6. The split-type degradable fallopian tube stent according to claim 1, characterized in that: The ampulla stent has a grid-like pore structure with a grid porosity of 85±5%. The surface is fixedly coated with a hyaluronic acid lubricating layer by an immersion-crosslinking method, and the degradation period is 7-9 months.

7. The split-type degradable fallopian tube stent according to claim 6, characterized in that: The grid structure diameter of the ampulla stent is 2.0±0.2 mm, the thickness of the hyaluronic acid lubricating layer is 2±0.5 μm, the cross-linking degree is greater than or equal to 80%, and the degradation period is 8 months.

8. A soft fallopian tube scope for delivering a split-type degradable fallopian tube stent, characterized by: Delivering the split degradable fallopian tube stent according to claims 1-7 to the target section of the fallopian tube, comprising a cervical probe, a soft fallopian tube scope and an imaging module; The soft fallopian tube mirror serves as a delivery channel, and the wireless module and the imaging module are used to transmit signals for imaging; The soft fallopian tube mirror passes through the external fixation bracket, the connecting pipe and the cervical insertion head from bottom to top and then extends into the operation area in the uterine cavity. The end of the soft fallopian tube mirror is provided with a magnetic navigation microcatheter, and the head end of the magnetic navigation microcatheter is provided with a neodymium iron boron magnet to support external magnetic field navigation positioning.

9. The soft fallopian tube scope for delivering a split-type degradable fallopian tube stent according to claim 8, characterized in that: The cervical probe is a trumpet-shaped structure with a hollow interior and a downward opening. The cervical probe is adjustable in curvature from 0 to 90 degrees via a universal joint. The lower end of the universal joint is connected to the external fixing bracket via a ball joint structure. A connecting pipe is provided in the middle of the universal joint. The external fixing bracket is a hollow tube structure and is fixedly arranged. The bending angle of the end of the soft fallopian tube mirror is greater than or equal to 270 degrees, and the magnetic force of the magnetic navigation microcatheter head end is greater than or equal to 0.3T; The soft fallopian tube mirror is positioned and marked, and an X-ray developing ring is set every 1 mm on the surface of the mirror body. The X-ray developing ring is made of platinum-iridium alloy, has a width of 0.1 mm, and a developing density greater than or equal to 300HU.

10. The soft fallopian tube scope for delivering a split-type degradable fallopian tube stent according to claim 8, characterized in that: 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, the diameter of which increases gradually from top to bottom to adapt to different cervical canal diameters, and the Shore hardness is 30A; The material of the cervical probe is thermoplastic polyurethane with a hardness of 40 Shore A and a hydrophilic lubricating layer coated on the surface; The imaging module uses optical fiber transmission, the optical fiber diameter is 0.2mm, and is equipped with a CMOS sensor with a resolution of 4K and an illumination brightness greater than or equal to 5000Lux; The outer diameter of the soft fallopian tube mirror is less than or equal to 2.4 mm, and it integrates ultra-fine optical fiber 4K imaging. The material is thermoplastic polyurethane with a hardness of 40 Shore A. The inner diameter of the soft fallopian tube mirror is 1.8 mm, and the delivery channel is 0.6-1.6 mm.

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