Reversible fallopian tube sterilization device and occlusion coil thereof

Abstract

The present invention discloses a reversible occluding spring coil, which is placed in the isthmus of the human fallopian tube for sterilization. The reversible occluding spring coil comprises: a spring coil body, which is formed by winding a spring wire to form a variable diameter spring structure, one end of the variable diameter spring structure is a large diameter end, and the other end is a small diameter end, and the diameter changes from the large diameter end to the small diameter end in a continuous arc; nylon fiber, including a nylon fiber line, which is wound around the spring wire along the extension direction of the spring wire and forms a tail line at the large diameter end of the spring coil body. The present invention also discloses a reversible fallopian tube sterilization device. The present invention can solve the technical problems of poor fixation effect in the isthmus, easy damage to the isthmus and difficulty in removal of the existing fallopian tube occlusion.

Description

Technical Field

[0001] The invention relates to a reversible fallopian tube sterilization device and an occluding spring coil thereof, belonging to the technical field of medical equipment. Background Art

[0002] Trans-tubal sterilization is one of the common methods of birth control for humans. It is widely accepted by women of childbearing age around the world because of its safety, reliability, and once-and-for-all advantages. In Asian and American countries, tubal sterilization has accounted for 30-33%, but tubal sterilization, including tubal ligation and silver clip closure of the fallopian tube, still has shortcomings, such as: the operation requires high anesthesia, there is a certain anesthesia risk, low reproducibility, many surgical complications and sequelae, and the recipient is prone to fear of surgery. The ideal birth control method should have the following characteristics: safe, reliable, simple, inexpensive, and reproducible.

[0003] Tubal occlusion is one of the methods of intra-tubal birth control, including adhesive occlusion and plugging. The drugs or polymer materials used in adhesive occlusion cause great damage to the fallopian tubes, which can easily lead to failure of adhesive occlusion, local tissue damage and adhesion, and the reversibility is very low, so it has been less studied so far. Common methods of tubal plugging include silicone rubber plugs, polyethylene plugs, nylon plugs, nickel-titanium alloy silicone rubber plugs, ESSURE, etc. For example, ESSURE is a small nickel-titanium alloy spring. In actual use, the applicant found that the tubal plugging of this structure has the following problems: First, the spring is too thick, resulting in too large a contact area between the surface and the tissue of the isthmus of the fallopian tube, which makes the spring easily incarcerated; second, the spring is too long, causing damage to the uterine cavity and fallopian tube. Third, the spring coil has the same diameter at both ends, which is not easy to fix after placement and is easy to fall off. Summary of the invention

[0004] Based on the above, the present invention provides a reversible fallopian tube sterilization device and an occlusion coil thereof to solve the technical problems of poor fixation effect in the isthmus and easy damage to the isthmus in the existing fallopian tube occlusion.

[0005] The technical solution of the present invention is: a reversible occluding coil, which is placed in the isthmus of the fallopian tube of a human body for sterilization, and the reversible occluding coil comprises:

[0006] The spring coil body is formed by winding spring wire to form a variable diameter spring structure, one end of the variable diameter spring structure is a large diameter end, and the other end is a small diameter end, and the variable diameter spring structure changes from the large diameter end to the small diameter end in a continuous arc;

[0007] The nylon fiber comprises a nylon fiber line, which is wound around the spring wire along the extension direction of the spring wire and forms a tail line at the large diameter end of the spring coil body. The tail end is left in the uterine cavity for easy removal in the future.

[0008] Optionally, the nylon fiber further includes scattering threads, and the scattering threads scatter outward from the nylon fiber thread.

[0009] Optionally, the nylon fiber is medical grade nylon fiber.

[0010] Optionally, the spring wire is made of shape memory material.

[0011] Optionally, the spring wire is made of platinum alloy, nickel-titanium alloy, stainless steel or other metal materials with good biocompatibility.

[0012] Optionally, the variable diameter spring structure has a small diameter end at the front with a diameter of 1 mm when in the spiral state, and a large diameter end as the tail end with a diameter of 3 mm and a height of 1 cm. In the straightened state, the length is 3 cm.

[0013] The present invention also provides a reversible fallopian tube sterilization device, comprising:

[0014] The recoverable occluding spring coil;

[0015] An inner catheter is vertically shaped and is suitable for accommodating the recoverable occluding spring coil in a straightened state;

[0016] A push rod wire, which can be inserted into the inner catheter and push the recoverable occluding spring coil to move forward in the inner catheter;

[0017] The outer catheter comprises a straight section and an inclined section, the inner diameters of the straight section and the inclined section match the outer shape of the inner catheter, and the inclined section forms an obtuse angle with the straight section.

[0018] Optionally, the inner catheter is made of a transparent medical polymer material, has scale marks every 1 cm at its front end, and the front edge contains a metal component.

[0019] Optionally, the outer catheter is made of medical polymer material, and the front 3 cm is made of transparent medical polymer material, with scale marks every 1 cm, and the front edge contains metal components.

[0020] The invention has the following beneficial effects: during sterilization surgery, the reversible plugging spring coil is firstly straightened into a vertical state and placed in the inner catheter, the inner catheter is installed in the outer catheter, the outer catheter is inserted into the uterine cavity through the vagina, the position of the front end inclined section of the outer catheter is adjusted by hysteroscopy or X-ray angiography, and the opening of the front end is aligned with the fallopian tube opening in the uterine cavity, the push rod wire is inserted into the inner catheter and enters the interstitial part and isthmus of the human fallopian tube through the outer catheter, and then the reversible spring coil is put into the inner catheter from the tail end, the push rod wire pushes the reversible plugging spring coil to move forward into the interstitial part and isthmus of the fallopian tube, and the inner catheter is withdrawn, and the reversible plugging spring coil is placed in the interstitial part and isthmus of the fallopian tube, at this time, the spring coil body is no longer pushed to move into the inside of the fallopian tube, and the two ends of the spring coil body are naturally squeezed toward the middle to form a cone-like structure, thereby blocking the space of the fallopian tube cavity, thereby preventing the egg from entering the uterine cavity, avoiding pregnancy, and achieving the purpose of sterilization. In the aforementioned process, the nylon fiber thread has two functions: first, it can increase the friction between the spring coil body and the muscles in the fallopian tube cavity, so that the spring coil body can be better fixed in the isthmus; second, with the help of the flexibility of the nylon fiber thread, it can reduce the damage of the spring coil body to the isthmus muscles. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 The recoverable occluding spring coil according to the embodiment of the present invention;

[0022] Figure 2 It is a structural schematic diagram of the spring coil body;

[0023] Figure 3 The reversible fallopian tube sterilization device according to the embodiment of the present invention;

[0024] Figure 4 A cross-sectional view of the outer catheter

[0025] Figure 5 is a cross-sectional view of the inner catheter;

[0026] Description of reference numerals:

[0027] 10 reversible occlusion coils, 20 inner catheters, 30 push rod wires, 40 outer catheters;

[0028] 11 spring coil body, 12 nylon fiber line, 13 scattering silk line, 14 tail line;

[0029] 41 is a straight segment, 42 is an inclined segment. DETAILED DESCRIPTION

[0030] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the specific embodiments of the present invention are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present invention. However, the present invention can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present invention, so the present invention is not limited by the specific implementation disclosed below.

[0031] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art of the present invention. The terms used herein in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention. The term "and / or" used herein includes any and all combinations of one or more related listed items.

[0032] See also Figure 1 and Figure 2 The embodiment of the present invention provides a reversible occluding coil, which is placed in the interstitial part and isthmus of the fallopian tube of the human body for sterilization. Specifically, the reversible occluding coil 10 is placed into the interstitial part and isthmus of the fallopian tube through the vagina and uterine cavity of the human body through hysteroscopy or X-ray mediated surgery to block the fallopian tube, thereby achieving the sterilization function.

[0033] The recoverable occluding spring coil 10 comprises a spring coil body 11 and nylon fibers, wherein:

[0034] The spring coil body 11 is formed by winding spring wire to form a variable diameter spring structure, one end of the variable diameter spring structure is a large diameter end, and the other end is a small diameter end, and the variable diameter spring structure changes in a continuous arc from the large diameter end to the small diameter end. The spring coil body 11 can be made by conventional methods, for example, the spring wire can be wound on a molding die and heated and cured to form a variable diameter spring structure.

[0035] In the natural state, the spring coil body 11 is in a spiral state. After being subjected to a tensile force, the spring coil body 11 can be stretched to a vertical state. After the force is removed, the spring coil body 11 in the vertical state will return to the spiral state. Preferably, the spring wire is made of a shape memory material, such as a platinum material, a platinum alloy, a tungsten material, a nickel-titanium material, a nickel-titanium alloy, a stainless steel material, or alloys formed between them and other metals.

[0036] In one example, the variable diameter spring structure has a diameter of 3 mm at the large diameter end, a diameter of 1 mm at the small diameter end, and a height of 1 cm when in a spiral state, and a length of 3 cm when in a straightened state, and a spring wire diameter of 0.5 mm. Of course, in other embodiments, the variable diameter spring structure can be selected according to the actual application requirements.

[0037] Since the length of the isthmus of the human body is generally 2-3cm, and the diameter is about 1mm. When the small diameter end of the spring coil body 11 in the straightened state extends into the isthmus, and the large diameter end is in the interstitial part, for example, when the small diameter end enters the isthmus by 1-1.5cm, the spring coil body 11 is no longer pushed to move into the isthmus. When the spring coil body 11 is not subjected to force, the two ends naturally squeeze toward the middle to form a cone-like structure, thereby blocking the space in the isthmus, thereby preventing the egg from entering the uterine cavity, avoiding pregnancy, and achieving the purpose of sterilization.

[0038] In one example, there is a tail line 14 at the large diameter end of the spring coil body 11. During surgery, the tail line 14 is left in the uterine cavity to facilitate finding and pulling when it is removed in the future.

[0039] The nylon fiber comprises a nylon fiber line 12, which is wound and fixed on the spring wire along the extension direction of the spring wire, and forms a tail line 14 at the large diameter end of the spring coil body 11. Preferably, the nylon fiber line 12 is evenly wrapped on the outer surface of the spring wire. The nylon fiber line 12 is wound on the spring wire, which has two effects: first, it can increase the friction between the spring coil body 11 and the muscles in the isthmus, so that the spring coil body 11 can be better fixed in the isthmus; second, with the help of the flexibility of the nylon fiber line 12, the damage of the spring coil body 11 to the isthmus muscles can be reduced. In addition, the tail line 14 is left in the uterine cavity after the operation for easy removal in the future.

[0040] The nylon fiber line 12 is wound around the spring wire by a conventional method, for example, the spring coil body 11 can be straightened into a vertical state first, and then the nylon line is fixed to one end of the spring wire, and then it is wound around the spring wire in a circle along the length direction, and fixed at the other end. After the nylon fiber line 12 is wound around the spring coil body 11, the diameter of the spring wire is greater than 0.5, but should be less than 1mm, so that the straightened reversible occlusion spring coil can enter the interstitial part and isthmus of the human fallopian tube. Those skilled in the art can select nylon fibers of appropriate diameter to be wound around the spring wire as needed.

[0041] The nylon fiber also includes scattering threads 13, which scatter outward from the nylon fiber thread 12. When the nylon fiber thread 12 is wound around the spring wire, one end of the scattering threads 13 is fixed on the nylon fiber thread 12, and the other end extends outward, so that when the spring coil body 11 contracts in the fallopian tube cavity, these scattering threads 13 can also be filled in the fallopian tube cavity, which can further improve the blocking effect. The scattering threads 13 can be fine wool threads that the nylon fiber thread 12 itself has and scatter outward.

[0042] Preferably, the nylon fiber is a medical grade nylon fiber to avoid the harm caused by the nylon fiber remaining in the human body.

[0043] Please also read Figures 1 to 5 The embodiment of the present invention is a reversible fallopian tube sterilization device, comprising a reversible occlusion coil, an inner catheter 20, a push rod wire 30 and an outer catheter 40. The device is mainly used to push the reversible occlusion coil into the isthmus of a human body.

[0044] The inner catheter 20 is vertical and has catheter holes running through both ends. The catheter holes are used to install the retractable plugging spring coil 10 in a straightened state, and the retractable plugging spring coil 10 can move in the catheter hole without shrinking. In one example, a scale is provided at the front end of the inner catheter 20, with one grid every 1 cm, which is mainly used to determine the depth of the inner catheter 20 entering the fallopian tube during operation.

[0045] The push rod wire 30 is vertical and can be inserted into the inner catheter 20 to push the reversible occluding spring coil 10 forward in the inner catheter 20. In one example, the top of the push rod wire 30 is rounded to reduce damage to the fallopian tube mucosa and easily form a good fit with the tail end of the spring coil, making it easier to push the spring coil.

[0046] The outer catheter 40 includes a straight section 41 and an inclined section 42. The inner diameters of the straight section 41 and the inclined section 42 are the same, but the outer diameter of the inclined section 42 is slightly smaller than the outer diameter of the straight section 41, which allows the inner catheter 20 and the reversible occlusion coil to move therein. The inclined section 42 is slightly thinner to facilitate the catheter to enter the gradually smaller uterine angle. The inclined section 42 and the straight section 41 form an obtuse angle, for example, it can be 150°, or it can be 120°, or it can be other obtuse angles, mainly to facilitate the adaptation of the fallopian tube to the left and right openings, and the opening of the catheter needs to be aligned with the fallopian tube opening. In one example, a scale is provided at the front end of the outer catheter 40, with one grid every 1 cm, which is mainly used to clarify the depth of the inner catheter 20 entering the fallopian tube during operation.

[0047] In one example, the inner catheter 20 is made of a transparent medical polymer material, with scale marks every 1 cm at the front end, and a metal component at the front edge. The outer catheter 40 is also made of a medical polymer material, with a transparent medical polymer material at the front end 3 cm, with scale marks every 1 cm, and a metal component at the front edge. The inner catheter 20 and the outer catheter 40 are made of transparent materials for easy observation and operation, the scale marks are for easy observation of the depth, and the metal component at the front edge is visible under X-ray, so that the operation can be completed under X-ray guidance, not just placed under hysteroscopy, which can effectively improve the operability of the operation.

[0048] It should be noted that the metal components at the front ends of the inner catheter 20 and the outer catheter 40 can be titanium alloys, etc., which can be wrapped in medical polymer materials as long as they can be identified and positioned under X-rays.

[0049] During the sterilization operation, the reversible plugging coil 10 is first straightened into a vertical state and placed in the inner catheter 20, the inner catheter 20 is installed in the outer catheter 40, the outer catheter 40 is inserted into the uterine cavity through the vagina, the front end inclined section 42 of the outer catheter 40 is positioned by hysteroscopy or X-ray angiography, and the front end opening is aligned with the fallopian tube opening in the uterine cavity, the push rod wire 30 is inserted into the inner catheter 20 and enters the interstitial part and isthmus of the human fallopian tube through the outer catheter 40, and then the reversible coil 10 is automatically inserted into the inner catheter 20. The tail end is placed in the inner catheter 20, and the push rod wire 30 pushes the reversible occluding spring coil 10 to move forward into the interstitial part and isthmus of the fallopian tube, and the inner catheter 20 is withdrawn, and the reversible occluding spring coil 10 is placed in the interstitial part and isthmus of the fallopian tube. At this time, the spring coil body 11 is no longer pushed to move inside the fallopian tube, and the two ends of the spring coil body 11 naturally gather and squeeze toward the middle to form a cone-like structure, thereby blocking the space in the isthmus, thereby preventing the egg from entering the uterine cavity, avoiding pregnancy, and achieving the purpose of sterilization. After completion, the inner catheter 20, the outer catheter 40 and the push rod wire 30 can be withdrawn.

[0050] When it is necessary to restore the patency of the fallopian tube, with the cooperation of hysteroscopy, a foreign body forceps is used to clamp the tail end of the reversible occlusion spring coil 10, such as the tail line 14, and then the reversible occlusion spring coil 10 is gently pulled to gradually separate from the isthmus and finally removed through the uterine cavity and vagina.

[0051] The above-mentioned embodiments only express several implementation methods of the present invention, and the description thereof is relatively specific and detailed, but it cannot be understood as limiting the scope of the patent of the present invention. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, which all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. A reversible fallopian tube sterilization device, characterized in that: include: A recoverable occluding spring coil (10) comprises: a spring coil body (11), which is formed by winding a spring wire to form a variable diameter spring structure, wherein one end of the variable diameter spring structure is a large diameter end and the other end is a small diameter end, and the variable diameter spring structure changes in a continuous arc from the large diameter end to the small diameter end; when the variable diameter spring structure is in a spiral state, the front part is a small diameter end with a diameter of 1 mm, and the large diameter end is a tail end with a diameter of 3 mm and a height of 1 cm; when it is in a straightened state, its length is 3 cm; nylon fiber, comprising a nylon fiber line (12), the nylon fiber line (12) is wound around the spring wire along the extension direction of the spring wire and forms a tail line (14) at the large diameter end of the spring coil body (11); the nylon fiber also comprises a scattering wire (13), and the scattering wire (13) scatters outward from the nylon fiber line (12); the spring wire is made of shape memory material; The inner catheter (20) is in a vertical shape, and is suitable for accommodating the reversible occluding spring coil in a straightened state. The inner catheter (20) is made of a transparent medical polymer material, and has scale marks every 1 cm at its front end, and the front edge contains a metal component; A push rod wire (30), wherein the push rod wire (30) can be inserted into the inner catheter (20) and push the recoverable occluding spring coil to move forward in the inner catheter (20); The outer catheter (40) comprises a straight section (41) and an inclined section (42); the inner diameters of the straight section (41) and the inclined section (42) match the outer shape of the inner catheter (20); and the inclined section (42) forms an obtuse angle with the straight section (41).

2. The reversible fallopian tube sterilization device according to claim 1, characterized in that: The outer catheter (40) is made of a medical polymer material, and the front 3 cm is made of a transparent medical polymer material, with scale marks every 1 cm, and the front edge contains a metal component.

3. The reversible fallopian tube sterilization device according to claim 1, characterized in that: The nylon fiber is medical grade nylon fiber.

4. The reversible fallopian tube sterilization device according to claim 1, characterized in that: The spring wire is made of platinum alloy, nickel-titanium alloy, stainless steel or other metal materials with good biocompatibility.

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