Degradable spring ring for female fallopian tube

Abstract

The invention provides a degradable spring ring for a female fallopian tube. The degradable spring ring is used for temporary plugging of the fallopian tube in gynecological inflammation treatment and assisted reproduction technologies. The spring ring is made of degradable materials, fibrous protrusions extend on the outer surface of the spring ring, and the spring ring is sequentially coated with an antibacterial medicine coating and a developing coating, so that anti-infection and intraoperative visualization functions are achieved. According to clinical requirements, the first class is divided into two classes: the degradation period is about 3 months, and a PLGA 50: 50 material is adopted and is suitable for preventing reflux of inflammatory media in the fallopian tube inflammation treatment period; the degradation period of the second type is about 2 years, the second type comprises three structures which are PLGA 85: 15, an AZ31 magnesium alloy skeleton or a magnesium alloy / PLGA composite structure, and the long-term plugging requirement in the test tube operation is met. The degradation rate is regulated and controlled through the material ratio, the functional coating and the structural design are combined, biocompatibility, operation safety and clinical adaptability are achieved, secondary operation taking-out can be avoided, and the gynecological diagnosis and treatment effect is remarkably improved.

Description

Technical Field

[0001] The present invention belongs to the technical field of biomedical materials, and specifically relates to a degradable spring coil device for fallopian tubes, which meets the needs of clinical anti-inflammatory treatment and assisted reproduction through differentiated degradation cycles and material design. Background Art

[0002] In the treatment of gynecological diseases in women of childbearing age, chronic salpingitis is treated with: 1. Anti-inflammatory medications; 2. Traditional Chinese medicine enemas; and 3. Pelvic therapy. Mild cases of chronic salpingitis require a long treatment cycle, a long time to be effective, and a long time to spend. Moderate to severe cases may also require: 1. Fluid insufflation; 2. Fallopian tube intervention; and 3. Laparoscopic hysteroscopy. Treatment is more time-consuming and expensive, tedious for patients, and often results in suboptimal outcomes.

[0003] During in vitro fertilization surgery and female contraceptive measures within two years, if water accumulates at the fimbria of the fallopian tube, the fallopian tube needs to be ligated or removed to prevent inflammatory mediators from flowing back into the uterine cavity and affecting embryo transfer. The fallopian tube can also be blocked with an occlusion device, but existing occlusion devices have the problem of requiring a second operation to remove or being retained for a long time, causing complications.

[0004] In order to address the problems of reflux of inflammatory mediators in the fallopian tube and uterine cavity contamination in assisted reproduction, it is urgent to develop a closure device with controllable degradation time. Summary of the Invention

[0005] The purpose of the present invention is to provide a degradable spring coil for female fallopian tubes to solve the problems raised in the above background technology:

[0006] (1) How to avoid the need for salpingectomy when the fallopian tubes are blocked?

[0007] (2) How to select biodegradable materials to overcome the problem that the degradation cycle of existing biodegradable materials does not match clinical needs and has a single function.

[0008] To achieve the above object, the present invention provides the following technical solutions:

[0009] A degradable spring coil for use in a woman's fallopian tube;

[0010] The main body of the degradable spring coil for female fallopian tubes is made of medical degradable materials.

[0011] On the basis of the above technical solution, the present invention can also be improved as follows.

[0012] Furthermore, the main body of the degradable spring coil for female fallopian tubes is made of degradable PLGA material.

[0013] Furthermore, the PLGA material of the degradable spring coil body for female fallopian tubes has a LA:GA ratio of 50:50.

[0014] Furthermore, the LA:GA ratio in the PLGA material of the degradable spring coil body for female fallopian tubes is 85:15.

[0015] Furthermore, the degradable spring coil for female fallopian tubes comprises an outer wrapping layer and an inner spring coil skeleton, wherein the spring coil skeleton is made of degradable AZ31 magnesium alloy material; the wrapping layer is made of PLGA material, and the LA:GA ratio in the PLGA material is 85:15.

[0016] Furthermore, a plurality of fibrous protrusions extend from the outer surface of the main body of the degradable spring coil used for female fallopian tubes.

[0017] Furthermore, the outer sides of the degradable spring coil and the fibrous protrusion for the female fallopian tube are coated with an antibacterial drug coating.

[0018] Furthermore, the outer side of the antibacterial drug coating is also coated with a developing coating.

[0019] Furthermore, the main body of the degradable spring coil for female fallopian tubes is made of degradable AZ31 magnesium alloy.

[0020] With this structure, the degradable spring coil for female fallopian tubes is divided into two categories according to different diseases:

[0021] The first type is a short-term occlusion type, with a degradation period of approximately three months. This biodegradable coil is placed in the inflamed area of ​​the patient's fallopian tube to prevent reinfection with inflammatory mediators during anti-inflammatory treatment. It is made of PLGA 50:50 (intrinsic viscosity 0.6-0.8 dL / g) and degrades within three to 0.5 months. It is used in acute salpingitis. Short-term occlusion supports and dilates the fallopian tubes, while also releasing medication to treat inflammation.

[0022] The second type is a long-term occlusion type, which degrades in about 2 years. This type of degradable spring coil for female fallopian tubes is suitable for in vitro fertilization surgery. The degradable spring coil for female fallopian tubes is placed in the patient's fallopian tubes, preventing inflammatory media from entering the uterine cavity along the fallopian tubes, thus achieving a occlusion effect. The second type includes three implementation plans:

[0023] (1) All-PLGA type, material: PLGA 85:15 (intrinsic viscosity 1.2-1.5 dL / g), in vitro degradation test: residual amount >80% after 24 months.

[0024] (2) Magnesium alloy main body type, material: AZ31 magnesium alloy (purity> 99.9%), surface treatment: micro-arc oxidation to form a 5-8μm ceramic layer.

[0025] (3) Composite structure type: the skeleton material is AZ31 magnesium alloy wire (diameter 0.2 mm), and the coating material is PLGA 85:15 (coating thickness 0.1 mm).

[0026] The advantages of this degradable spring coil for female fallopian tubes compared to traditional surgical procedures are:

[0027] (1) Trauma and recovery period: interventional occlusion does not require laparotomy or laparoscopy. Patients can be discharged on the same day after surgery, and the recovery period is shortened to 1-3 days (traditional laparoscopic surgery requires 2 weeks).

[0028] (2) Protection of ovarian function: Compared with traditional salpingectomy, salpingectomy reduces the impact of ovarian blood supply by 90%, and there is no significant decrease in anti-Mullerian hormone (AMH) levels after surgery.

[0029] (3) Existing clinical data indicate that degradable occlusion coils have significant advantages in the treatment of hydrosalpinx and assisted reproduction, particularly in terms of minimal invasiveness, preservation of ovarian function, and improved postoperative pregnancy rates. Future studies should expand the sample size and conduct long-term follow-up (>5 years) to verify the long-term safety of the degradation products and their potential for restoring fallopian tube function. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 It is a stereoscopic diagram of the first embodiment of the degradable spring coil for female fallopian tube.

[0031] Figure 2 This is a front view of the first embodiment of the degradable spring coil for female fallopian tubes.

[0032] Figure 3 This is a development diagram of Example 1 of the degradable spring coil for female fallopian tube after implantation into the fallopian tube.

[0033] Figure 4 This is a cross-sectional view of the main body of the degradable spring coil for female fallopian tubes in the fifth embodiment of the degradable spring coil for female fallopian tubes.

[0034] Description of the numbers in the figure:

[0035] A degradable spring coil body 100 for use in female fallopian tubes; a spring coil frame 110; and a wrapping layer 120. DETAILED DESCRIPTION

[0036] To make the above-mentioned objects, features, and advantages of the present invention more readily apparent, specific embodiments of the present invention are described in detail below with reference to the accompanying drawings. The following description sets forth numerous specific details to facilitate a full understanding of the present invention. However, the present invention can be implemented in many other ways than those described herein, and those skilled in the art may make similar modifications without departing from the scope of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0037] The terms "vertical," "horizontal," "left," "right," and the like as used herein are for illustrative purposes only and do not represent the only implementations.

[0038] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this invention pertains. The terms used in this specification of the present invention are for the purpose of describing specific embodiments only and are not intended to limit the present invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0039] Example 1

[0040] See also Figures 1 to 2 .

[0041] The degradable spring coil body 100 for the female fallopian tube is made of a medically-grade degradable material. The degradable spring coil body 100 is made of a degradable PLGA material (poly(lactic-co-glycolic acid)). The PLGA material of the degradable spring coil body 100 has a 50:50 ratio of LA to GA, resulting in a high GA ratio and strong hydrophilicity.

[0042] The PLGA material in this embodiment is intended to achieve a PLGA coil that degrades within the fallopian tube within 3 months.

[0043] The PLGA material used in this biodegradable spring coil for female fallopian tubes is PLGA 50:50 (LA:GA = 50:50). The PLGA material in this embodiment has a low-to-medium molecular weight (10-30 kDa), which shortens the main chain hydrolysis time. The PLGA material also contains additives, specifically 5-10% polyethylene glycol (PEG), to enhance hydrophilicity and accelerate fluid penetration.

[0044] The porosity of the biodegradable spring coil body 100 for female fallopian tubes is greater than 90%, increasing the contact area with body fluids. Several fibrous protrusions (not shown) extend from the outer surface of the biodegradable spring coil body 100. These protrusions can also be made of PLGA, using nano-scale fibers (100-300 nm) (e.g., electrospinning) to accelerate hydrolysis.

[0045] The degradable spring coil and fibrous protrusion used in the female fallopian tube are coated with a developing coating on the outside. The developing coating uses barium sulfate or iohexol as a developer to facilitate positioning under X-ray or ultrasound.

[0046] The degradable spring coil for female fallopian tubes is placed in the inflamed part of the patient's fallopian tube (or in the isthmus of the fallopian tube) to prevent the inflammatory mediators in the ovary from re-infecting the affected part during the anti-inflammatory treatment.

[0047] Figure 3 This image shows an angiogram of a patient's fallopian tube. During the first four weeks of use, the PLGA backbone of this biodegradable coil rapidly hydrolyzes, gradually decreasing the scaffold's strength and prioritizing degradation of the GA portion. Between four and 12 weeks, the scaffold disintegrates into fragments, which are then phagocytosed by macrophages and metabolized by enzymes, leading to complete absorption within three months.

[0048] This degradable spring coil for female fallopian tubes is a short-term degradable coil (3 months), and has been tested for its effectiveness in immediate occlusion based on clinical data:

[0049] In clinical trials of hydrosalpinx occlusion, the immediate success rate of the interventional occlusion system can reach 100%. The operation takes an average of 20 minutes and does not require anesthesia. The fibrous protrusion design can increase friction with the fallopian tube wall to prevent slippage. Combined with antibacterial drug coating (such as silver ion-containing polyurethane), the postoperative infection rate can be controlled below 5%.

[0050] The 3-month degradation cycle of the PLGA 50:50 material matches the inflammatory treatment period. Animal studies have shown that the PLGA degradation products (lactic acid and glycolic acid) do not induce a significant local inflammatory response, and the fallopian tube mucosa is completely repaired after degradation without fibrotic scarring.

[0051] The incidence of adverse events within 3 months after surgery was less than 5%, mainly mild abdominal pain (3.2%) and transient vaginal bleeding (1.8%), without serious infection or perforation.

[0052] Example 2

[0053] The only difference between this embodiment and the first embodiment is that the degradable spring coil and the fibrous protrusion used in the female fallopian tube are also coated with an antibacterial drug coating. The antibacterial drug coating can specifically be a parylene coating or a silver-loaded zirconium phosphate or quaternary ammonium salt antibacterial agent, and the developing coating is coated on the outside of the antibacterial drug coating.

[0054] Example 3

[0055] The only difference between this embodiment and the first embodiment is that the LA:GA ratio of the PLGA material of the degradable spring coil body 100 for female fallopian tubes is 85:15, and the high LA ratio delays degradation.

[0056] The PLGA material in this embodiment is intended to achieve a PLGA coil that degrades in the fallopian tube within 2 years.

[0057] The PLGA material used in the degradable spring coil for female fallopian tubes is PLGA 85:15 (LA:GA=85:15), and the high LA ratio delays degradation.

[0058] The PLGA material of this embodiment has a high molecular weight (80-150 kDa) to prolong the ester bond cleavage time. The PLGA material also contains additives, specifically 10-20% polycaprolactone (PCL), to form a hydrophobic barrier and slow down water penetration.

[0059] The porosity of the degradable spring coil body 100 for female fallopian tubes is low (<30%) and compact, minimizing contact with body fluids. The outer surface of the degradable spring coil body 100 also includes a number of fibrous protrusions, constructed from micron-sized fibers (5-20 μm) to reduce the specific surface area.

[0060] The biodegradable coil for female fallopian tubes undergoes slow degradation of the outer PLLA coating over a period of 0-12 months, while the PLGA core undergoes only slight hydrolysis at the surface, maintaining mechanical strength. After the coating is completely degraded over a period of 12-24 months, the PLGA core begins to hydrolyze and gradually absorbs over a two-year period.

[0061] The degradable spring coil for female fallopian tubes in this embodiment is suitable for in vitro fertilization surgery. The degradable spring coil for female fallopian tubes is placed in the patient's fallopian tubes, and no inflammatory mediators in the ovaries will enter the uterine cavity along the fallopian tubes, thereby playing a blocking role.

[0062] In clinical trials, the in vitro degradation experiment of the degradable spring coil for female fallopian tubes in this embodiment showed that the residual material amount was greater than 80% after 24 months.

[0063] In patients who used long-term occluders before in vitro fertilization (IVF-ET), the success rate of embryo transfer 6 months after surgery was 30% higher than that of traditional surgery (the success rate of the control group was about 50%, and the success rate of using the degradable spring coil for female fallopian tubes in this embodiment could reach 80%).

[0064] Postoperative follow-up showed that the fallopian tube patency rate recovered to 80% after the occluder degraded, making natural conception possible (for example: after occlusion of patients with unilateral hydrops, the natural conception rate of the normal fallopian tube increased).

[0065] The cumulative postoperative complication rate was approximately 8%, including local inflammatory reaction in the early stage of degradation (4.5%) and occasional mild edema of the fallopian tube mucosa (3.5%), both of which were relieved by anti-inflammatory treatment.

[0066] Example 4

[0067] The only difference between this embodiment and the third embodiment is that the degradable spring coil body 100 for female fallopian tubes is made of degradable AZ31 magnesium alloy, and a 5-8 μm ceramic layer is formed on the surface of the degradable spring coil for female fallopian tubes by micro-arc oxidation.

[0068] The degradable spring coil used for the female fallopian tube in this embodiment will also gradually degrade after 24 months.

[0069] Example 5

[0070] The only difference between this embodiment and the third embodiment is that:

[0071] See also Figure 4 The degradable spring coil for female fallopian tubes includes an outer wrapping layer 120 and an inner spring coil frame 110. The spring coil frame 110 is made of degradable AZ31 magnesium alloy material, and the diameter of the spring coil frame 110 is 0.2 mm; the wrapping layer 120 is made of PLGA material (the wrapping layer 120 in this embodiment is consistent with the PLGA material in Example 3), the LA:GA ratio in the PLGA material is 85:15, and the thickness of the wrapping layer 120 is 0.1 mm.

[0072] The above are only five embodiments of the present invention. It should be pointed out that for ordinary technicians in this field, several modifications and improvements can be made without departing from the principles of the present invention, and these should also be regarded as falling within the scope of protection of the present invention.

Claims

1. A degradable spring coil for use in female fallopian tubes, characterized by: The main body of the degradable spring coil for female fallopian tubes is made of medical degradable materials.

2. The degradable spring coil for female fallopian tube according to claim 1, characterized in that: The main body of the degradable spring coil for female fallopian tubes is made of degradable PLGA material.

3. The degradable spring coil for female fallopian tube according to claim 2, characterized in that: The PLGA material of the degradable spring coil body for female fallopian tubes has a LA:GA ratio of 50:

50.

4. The degradable spring coil for female fallopian tube according to claim 2, characterized in that: The PLGA material of the degradable spring coil body for female fallopian tubes has an LA:GA ratio of 85:

15.

5. The degradable spring coil for female fallopian tube according to claim 4, characterized in that: The degradable spring coil for female fallopian tubes comprises an outer wrapping layer and an inner spring coil frame, wherein the spring coil frame is made of degradable AZ31 magnesium alloy material; the wrapping layer is made of PLGA material, wherein the LA:GA ratio in the PLGA material is 85:

15.

6. The degradable spring coil for female fallopian tube according to claim 4, characterized in that: The outer surface of the main body of the degradable spring coil used for female fallopian tubes is provided with a plurality of fibrous protrusions.

7. The degradable spring coil for female fallopian tube according to claim 6, characterized in that: The outer sides of the degradable spring coil and the fibrous protrusion used for the female fallopian tube are coated with an antibacterial drug coating.

8. The degradable spring coil for female fallopian tube according to claim 7, characterized in that: The outer side of the antibacterial drug coating is also coated with a developing coating.

9. The degradable spring coil for female fallopian tube according to claim 1, characterized in that: The main body of the degradable spring coil for female fallopian tubes adopts degradable AZ31 magnesium alloy.

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