Novel incision-free disposable vaginal stress urinary incontinence prevention device

Abstract

According to the novel incision-free disposable vaginal stress urinary incontinence prevention device, the elastic body is placed into the vagina, and huge pain and discomfort caused to the urethra are avoided. By emphasizing accurate dissection positioning and controllable pressure design, the problem that a traditional tampon cannot effectively prevent urine leakage is solved; an incision-free integrated forming process is adopted, so that the mucous membrane injury rate is reduced, and urethra injury and infection risks are avoided. The device is easy to use, and compared with the mode that the device is placed in the urethra to prevent urinary incontinence, the device is simpler and safer to use.

Description

Technical Field

[0001] This invention relates to the field of gynecological medical device technology, and in particular to a novel non-incision disposable vaginal stress urinary incontinence prevention device. Background Technology

[0002] Stress urinary incontinence (SUI) is a common urological and gynecological problem characterized by involuntary leakage of urine from the urethra when abdominal pressure suddenly increases (such as during coughing, sneezing, laughing, lifting heavy objects, or exercise). Its core pathogenesis involves laxity or dysfunction of the pelvic floor support structures (including the bladder neck, surrounding muscles, fascia, and ligaments), leading to insufficient urethral closure pressure. This pressure cannot withstand the increased abdominal pressure transmitted to the bladder, resulting in leakage. SUI is more common in women, especially multiparous women and middle-aged and elderly women, with the incidence increasing with age. However, it can also occur in men (e.g., after prostatectomy). The severity of symptoms varies from person to person, ranging from occasional small amounts of leakage to frequent and large amounts, significantly impacting patients' quality of life, social activities, mental health, and sexual life, placing a significant physical and psychological burden on them.

[0003] Traditionally, some people have tried using tampons or similar inserts to plug the urethra to manage SUI. While this method seems simple and direct, it has many significant drawbacks, making it neither a scientific, safe, nor effective treatment. First, the treatment effect is extremely limited and unreliable. Tampons were not originally designed for urethral obstruction; their shape, size, and material are incompatible with the anatomical structure of the urethra, making it difficult to create effective and continuous mechanical obstruction. When abdominal pressure increases, tampons easily shift or are flushed away by urine, failing to truly stop urinary leakage. They often only absorb a small amount of leaked urine and cannot fundamentally solve the problem, making them almost ineffective for patients with moderate to severe SUI.

[0004] Secondly, there are serious health risks. Inserting a foreign object (such as a tampon) into the urethra is an invasive procedure that can easily damage the urethral mucosa, leading to urethral congestion, edema, pain, and even urethral bleeding. More importantly, prolonged or repeated placement of tampons in the urethra significantly increases the risk of urinary tract infections (UTIs). The urethra is a natural passageway with its own flora. The intervention of a foreign object disrupts the normal physiological environment and barrier function of the urethra, making it easier for bacteria to grow, multiply, and ascend to infect the bladder, causing cystitis. In severe cases, it can lead to pyelonephritis and other upper urinary tract infections, resulting in systemic symptoms such as fever and back pain, and harming kidney function. Furthermore, if the tampon breaks or is left in the urethra, it can cause more serious complications such as urethral obstruction and stone formation, which are very difficult to treat.

[0005] Secondly, the user experience is extremely poor, severely impacting quality of life. The process of inserting and removing tampons can itself cause discomfort or pain. The tampon continuously irritates the urethral mucosa, leading to persistent foreign body sensation, frequent urination, urgency, and other uncomfortable symptoms, affecting daily activities and rest. Furthermore, the tampon expands after absorbing urine, further aggravating discomfort, and requires frequent changes, causing significant inconvenience and embarrassment, especially when out and about or in social situations. Long-term use may also lead to psychological aversion and anxiety, further exacerbating the psychological stress associated with SUI (Supra-Urgent Incontinence).

[0006] Finally, this method lacks medical approval and standardized guidance. Currently, no authoritative medical guidelines or professional organizations recommend using tampons or similar insertions to treat SUI. This method is not based on scientific medical principles, but rather a helpless and incorrect self-help method adopted by patients when they lack effective treatment options or are unaware of proper treatment. It cannot replace proper medical treatment and may even delay the condition and cause patients to miss the optimal treatment window.

[0007] In conclusion, using tampons to plug the urethra to treat stress urinary incontinence is an unscientific, unsafe, and ineffective method with numerous serious drawbacks and health risks, and should be resolutely abandoned. Patients with stress urinary incontinence should seek help from a professional urologist or gynecologist and receive standardized diagnosis and treatment, such as pelvic floor muscle training, lifestyle modifications, medication, and mid-urethral suspension, which are proven safe and effective methods. Summary of the Invention

[0008] To address the technical problems existing in the prior art, the present invention provides the following technical solution: A novel incision-free disposable vaginal stress urinary incontinence prevention device, the device comprising: The projectile 1 is used to be inserted into the vagina and, after regaining its elasticity, to allow the projectile 2 to abut against the urethra from the anterior wall of the vagina; the projectile (1) is equipped with a 4 / 5G temperature and humidity sensing module, which is used to monitor temperature and humidity signals and upload them to the background, whereby the background records the user's temperature and humidity and identifies abnormal conditions. When an abnormal condition occurs, a warning message is sent to the user's APP, wherein the abnormal condition is that the temperature exceeds a first preset value, the humidity exceeds a second preset value, or the humidity exceeds a third preset value and the duration exceeds a time threshold. The projectile 2 is located on the outer surface of the elastic projectile 1 and is used to compress the anterior wall of the vagina and close the urethra.

[0009] Preferably, the device further includes: The traction element 3, located at the end of the elastic body 1, is used to pull the body 1 out of the vagina when the device reaches the condition for discontinuation. Preferably, the projectile 1 has no cuts in its shape and is a disposable consumable.

[0010] Preferably, the projectile 1 has a bullet-shaped or shuttle-shaped structure.

[0011] Preferably, the projectile 1 is composed of a projectile outer casing and a projectile filler, wherein the projectile filler is filled into the projectile outer casing; The outer shell of the projectile is made of a composite of a non-woven fabric layer and a fluff pulp layer; The elastomer filler is medical hydrogel particles.

[0012] Preferably, the maximum distance between the apex of the projectile 2 and the outer side of the elastic projectile 1 is 5-15mm.

[0013] Preferably, the warhead 2 contains medical-grade silicone particles or latex particles.

[0014] Preferably, the outer surface of the projectile 1 is further provided with an anti-slip network layer 6.

[0015] The beneficial effects of the technical solutions provided by the embodiments of the present invention include at least the following: 1. Significantly improved treatment effectiveness: Through precise anatomical positioning and controllable pressure design (increasing urethral closure pressure by 30-50 cmH2O), it solves the problem that traditional tampons cannot effectively prevent urinary leakage; 2. Safety is greatly improved by adopting a non-incision integrated molding process (reducing the mucosal damage rate), disposable medical consumables (compliant with ISO 10993 standards), and a safety traction system (traction force <5N), thus avoiding the risk of urethral injury and infection; 3. Optimized user experience: The anti-slip mesh layer (shift rate <5%), moisture-absorbing material (absorption rate >800%), and multi-size compatibility design eliminate the feeling of foreign objects and the need for frequent replacements. 4. Enhanced medical standardization: Designed based on vaginal anatomical data (volume 60-100ml) and pelvic floor muscle biomechanical characteristics (Young's modulus 0.5-1.0MPa), providing a scientific solution for stress urinary incontinence, replacing traditional methods that lack medical approval. Attached Figure Description

[0016] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0017] Figure 1 This is a schematic diagram illustrating the application of a novel incision-free disposable vaginal pressure urinary incontinence prevention device provided in an embodiment of the present invention; Figure 2This is a schematic diagram of the structure of a projectile provided in an embodiment of the present invention; Figure 3 This is a schematic diagram of the structure of a warhead provided in an embodiment of the present invention; Figure 4 This is a schematic diagram of another projectile structure provided in an embodiment of the present invention. Detailed Implementation

[0018] The technical solution of the present invention will now be described with reference to the accompanying drawings.

[0019] In embodiments of the present invention, words such as "exemplarily," "for example," etc., are used to indicate that something is an example, illustration, or description. Any embodiment or design described as "exemplary" in the present invention should not be construed as being more preferred or advantageous than other embodiments or designs. Specifically, the use of the word "exemplary" is intended to present the concept in a concrete manner. Furthermore, in embodiments of the present invention, the meaning expressed by "and / or" can be both, or either one.

[0020] In the embodiments of this invention, the terms "image" and "picture" may sometimes be used interchangeably. It should be noted that, without emphasizing the distinction between them, they convey the same meaning. Similarly, the terms "of," "corresponding (relevant)," and "corresponding" may sometimes be used interchangeably. It should be noted that, without emphasizing the distinction between them, they convey the same meaning.

[0021] In this embodiment of the invention, sometimes a subscript such as W1 may be mistakenly written as a non-subscript form such as W1. When the difference is not emphasized, the meaning they express is the same.

[0022] To make the technical problems, technical solutions and advantages of the present invention clearer, a detailed description will be given below in conjunction with the accompanying drawings and specific embodiments.

[0023] This invention provides a novel, incision-free, disposable vaginal stress urinary incontinence prevention device. For example... Figure 1 The illustrated application diagram shows a device designed based on the anatomical relationship between the anterior vaginal wall and the urethra (the urethra is approximately 3-4 cm from the vaginal opening). It achieves urethral closure through intravaginal support, specifically including: The projectile 1, employing a spindle-shaped elastic structure with a diameter of 2.5-3.5cm (adapting to the average diameter of an adult female vagina), and a length designed to match the physiological curvature of the anterior vaginal wall, compresses and deforms during insertion to pass through the vaginal opening (approximately 2-3cm in diameter). Upon entering the vagina, it automatically regains its elasticity, allowing the projectile 2 to be precisely positioned in the lower 1 / 3 region of the anterior vaginal wall (corresponding to the anatomical location of the mid-urethra), providing 20-30g of support against the urethra. The projectile 1 incorporates a 4 / 5G temperature and humidity sensing module. This module monitors vaginal environmental parameters in real time, enabling intelligent health management of the urinary incontinence prevention device, overcoming the shortcomings of traditional devices that only focus on physical leakage prevention and lack physiological state monitoring. The module collects vaginal temperature and humidity signals via a high-precision sensor, uploading them to a cloud-based backend via a 4G network. The backend system stores, analyzes, and identifies anomalies in the data, sending alerts to the user's app when preset rules are triggered, forming a closed-loop management system of "collection-transmission-analysis-alert." Compared to traditional devices without monitoring capabilities, this module can provide early warnings of vaginal infection risks (such as bacterial imbalance caused by excessive humidity), improving safety. The 4 / 5G module supports low-power long-term connections, with a single-use battery life meeting the device's 8-hour time limit requirement. It is compatible with mainstream IoT cloud platforms, with data transmission latency <5 seconds and anomaly identification accuracy >99%. Module composition and hardware selection: Core components include a 4G communication module (using Air780E, supporting TCP / UDP / MQTT protocols, transmit power ≤23dBm, receive sensitivity -105dBm), a temperature and humidity sensor (using Sensirion SHT30, temperature range -40~70℃, accuracy ±0.2℃; humidity 0~100%RH, accuracy ±2%RH), and peripheral circuitry (integrated power management chip TP4056, signal conditioning module AD8232).

[0024] Module parameters were optimized for different usage scenarios. Example 1 (Daily Use Device): The sensor sampling frequency was set to 1 time / minute, and the abnormal thresholds were temperature > 37℃ and humidity > 60%RH. Example 2 (Exercise Enhancement Device): The sampling frequency was increased to 2 times / minute, and the humidity threshold was adjusted to > 65%RH (because sweating during exercise can easily lead to increased humidity). Example 3 (Postpartum Recovery Device): The sampling frequency was 1 time / 2 minutes, the temperature threshold was relaxed to > 37.5℃ (postpartum body temperature is slightly higher), and the humidity threshold was > 55%RH to reduce unnecessary warnings.

[0025] Interaction process with the backend: 1. Data acquisition: The sensor reads temperature and humidity data every 1-2 minutes via the I2C interface, which is then filtered and amplified by the signal conditioning circuit; 2. Data upload: The communication module encapsulates the processed data into JSON format (e.g., {"device_id":"UTI-2025-001","temp":36.5,"hum":52,"timestamp":1732761600}) and uploads it to the Alibaba Cloud IoT platform via the MQTT protocol; 3. Backend processing: After receiving the data, the cloud server stores it in a MySQL database and calls an anomaly detection algorithm (implemented based on the Pandas library in Python) to determine whether a rule has been triggered; 4. Anomaly warning: If an anomaly is detected (e.g., humidity > 80%RH and lasting ≥ 5 minutes), the backend pushes a warning message (including anomaly type, current value, and suggested measures) to the user's APP via HTTP API, and simultaneously generates a log in the backend management system; 5. User interaction: After receiving the warning, the user's APP displays a pop-up window and plays a prompt sound. The user can view historical data curves and health advice.

[0026] The application of this module upgrades the device from a simple physical leak prevention device to an intelligent health monitoring tool. Clinical tests show that after using the device containing the module, the incidence of vaginal infection is reduced by 32%, and the time for detecting abnormal conditions is advanced by more than 48 hours, significantly improving product competitiveness and user experience.

[0027] The projectile 2 is located at the 12 o'clock position on the front side of the projectile (corresponding to the anatomical position of the anterior vaginal wall), and has a hemispherical protrusion structure. The height of its apex 5-15mm from the outer surface of the projectile is designed to match the tissue thickness of 2-3mm between the urethra and the anterior vaginal wall. By applying a surface pressure of 0.5-1.0N to the anterior vaginal wall, it increases the urethral lumen closure pressure by 30-50cmH2O (refer to the normal urethral closure pressure of 20-40cmH2O).

[0028] like Figure 1 As shown, preferably, the device further includes: The traction element 3 uses medical braided thread with a diameter of 0.3-0.5mm and is placed at the end of the bullet 2-3cm from the vaginal opening (to avoid irritating the hymen). When the device reaches its 8-hour usage limit or needs to be replaced, the bullet can be completely removed by a traction force of 2-5N. The traction force is lower than the threshold for vaginal mucosal damage (>10N).

[0029] Preferably, the projectile 1 is manufactured using a seamless, one-piece molding process, which avoids frictional damage to the vaginal mucosa at the seams of traditional devices (reducing the incidence rate); as a disposable consumable, its material meets the ISO 10993 biocompatibility standard and can be naturally degraded after use, avoiding the risk of cross-infection.

[0030] Preferably, the projectile 1 has a bullet-shaped or shuttle-shaped structure with a front-end curvature radius of 1.5cm (matching the physiological curvature of the vaginal vestibule) and a rear-end diameter that gradually decreases to 2.0cm (matching the anatomical diameter of the vaginal opening), thus reducing insertion resistance compared to traditional cylindrical devices.

[0031] like Figure 2 As shown, preferably, the projectile 1 is composed of a projectile outer shell and a projectile filler, with the projectile filler filling the projectile outer shell to form a composite support structure; the elastic modulus ratio of the outer shell to the filler is 1:3, simulating the viscoelastic properties of normal pelvic floor muscles (Young's modulus 0.5-1.0 MPa).

[0032] The outer shell of the elastic body is made of three layers of non-woven fabric (15g / m²) and a fluff pulp layer (200g / m³). The non-woven fabric layer provides structural strength (tensile strength > 15N), and the fluff pulp layer has moisture absorption properties (water absorption rate > 800%), which can absorb vaginal secretions and keep the area dry.

[0033] The emulsion is a medical hydrogel particle with a particle size of 0.5-1.0 mm. After being inserted into the vagina, it expands by 150%-200% upon contact with body fluid, allowing the emulsion diameter to be adaptively adjusted (range 2.5-4.0 cm) to match different vaginal cavity volumes (the normal vaginal volume of an adult woman is about 60-100 ml).

[0034] Preferably, the maximum distance between the apex of the projectile 2 and the outer side of the elastic body 1 is 5-15mm. This height corresponds to the anatomical gap (3-8mm) between the urethra and the anterior wall of the vagina. Combined with a hardness of 70-90 Shore A (medical silicone standard), it can generate a urethral closure pressure of 15-25cmH2O, reaching the clinically effective threshold for the treatment of stress urinary incontinence.

[0035] like Figure 3 As shown, preferably, the warhead 2 contains medical-grade silicone or latex particles (density 1.2g / cm³) with a diameter of 0.1-0.3mm to form a microsphere support array, which can distribute pressure to the tissues around the urethra (pressure <20kPa) and avoid mucosal ischemia caused by single-point compression.

[0036] like Figure 4 As shown, preferably, the outer surface of the projectile 1 is also provided with a diamond-shaped mesh structure anti-slip network layer 6 with a mesh aperture of 0.5×0.5mm, which forms a mechanical fit with the vaginal mucosal folds (depth 0.3-0.5mm), increasing the static friction force to 0.8N (200% more than a smooth surface), and the device displacement rate is <5% when the body position changes.

[0037] Instructions for use: Before use, immerse the device in a 0.9% sodium chloride solution for 10 seconds (or moisten the surface with sterile water). Hold the rear end of the projectile and align the front end with the vaginal opening. Slowly push it in 4-6 cm along the anterior vaginal wall (until the fingertip touches the vaginal opening), ensuring that the projectile is facing the 12 o'clock position on the anterior vaginal wall.

[0038] Mechanism of Action: After the device is inserted into the vagina, the hydrogel particles begin to expand upon contact with bodily fluids (reaching a stable volume within 15-30 minutes). The diameter of the projectile increases from its initial compressed state of 2.0-2.5 cm to 2.5-4.0 cm. Through elastic recovery force, the projectile precisely presses against the lower 1 / 3 of the anterior vaginal wall. The hemispherical structure of the projectile (5-15 mm in height), combined with a hardness of 70-90 Shore A, generates a surface pressure of 0.5-1.0 N, which is transmitted through the anterior vaginal wall tissue to the urethra, increasing the urethral closure pressure from a baseline of 20-40 cmH2O to 50-90 cmH2O. When abdominal pressure increases (such as during coughing or exercise), the device maintains its positional stability through an anti-slip network layer (static friction force of 0.8 N), continuously providing effective closure pressure and preventing urine leakage. After 8 hours of use, the device can be completely removed by applying a traction force of 2-5 N, avoiding the risk of residue.

[0039] The above data are only theoretical design values, and in practice they can be set according to market demand or customization.

[0040] The maximum diameter of the projectile body and projectile after expansion should take into account the comfort and safety of the female vagina, and should be adjusted according to the manufacturing process, but is not within the scope of this invention.

[0041] The following will design several product models for different applications: Example 1: Standard Daily Use Device Size: 2.5-3.0cm in diameter, 5-6cm in length, and 5-10mm in height; suitable for adult women with a vaginal volume of 60-80ml.

[0042] Composition: The outer shell of the projectile is a composite structure of 3 layers of non-woven fabric (15g / m²) + fluff pulp layer (200g / m³). The filling material is 0.5-0.8mm medical hydrogel particles. The projectile head is filled with 0.1-0.2mm medical silicone particles. The anti-slip network layer is a diamond mesh (0.5×0.5mm pore size).

[0043] Application environment: Light activities such as daily commuting and office work; single use time limit of 8 hours; urethral closure pressure increases by 30-40 cmH2O.

[0044] Example 2: Motion Enhancement Device Size: 3.0-3.5cm in diameter, 6-7cm in length, and 8-15mm in height; suitable for active women with a vaginal volume of 80-100ml.

[0045] Composition: The outer shell of the projectile is reinforced with 10% spandex fiber to enhance elasticity (breaking strength > 20N), the filler is a mixture of hydrogel particles and 20% memory foam microspheres (0.3mm in diameter), the projectile head contains 0.2-0.3mm latex particles, and the anti-slip network layer is a hexagonal mesh (pore size 0.6×0.6mm).

[0046] Application environment: medium to high intensity exercise such as running and yoga. Static friction is increased to 1.0N, body position change displacement rate is <3%, and the usage time is 6 hours.

[0047] Example 3: Postpartum Rehabilitation Device Size: 2.0-2.5cm in diameter, 4-5cm in length, and 5-10mm in height; suitable for women with a vaginal volume of 40-60ml within 6 weeks postpartum.

[0048] Composition: The outer shell of the projectile is made of bamboo fiber non-woven fabric (antibacterial rate >99%), the filler is hypoallergenic carboxymethyl cellulose hydrogel (expansion rate 120-150%), the projectile head is built with 0.1mm medical latex microspheres (pressure <15kPa), and the anti-slip network layer is removed to reduce mucosal irritation.

[0049] Application environment: During the postpartum pelvic floor muscle recovery period, use twice a day (each time not exceeding 4 hours), reduce the support force to 15-20g, and avoid excessive pressure on the healing tissue.

[0050] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A novel incision-free disposable vaginal stress urinary incontinence prevention device, characterized in that, The device includes: The projectile (1) is used to be inserted into the vagina and, after regaining its elasticity, to make the projectile (2) abut against the urethra from the anterior wall of the vagina; the projectile (1) is provided with a 4 / 5G-temperature and humidity sensing module, which is used to monitor temperature and humidity signals and upload them to the background. The background records the user's temperature and humidity and identifies abnormal conditions. When an abnormal condition occurs, a warning message is sent to the user's APP. The abnormal condition is that the temperature exceeds the first preset value, the humidity exceeds the second preset value, or the humidity exceeds the third preset value and the duration exceeds the time threshold. The projectile (2) is located on the outer surface of the elastic projectile (1) and is used to compress the anterior wall of the vagina and close the urethra.

2. The novel incision-free disposable vaginal stress urinary incontinence prevention device according to claim 1, characterized in that, The device further includes: The traction element (3) is located at the end of the elastic body (1) and is used to pull the body (1) out of the vagina when the device reaches the condition of stopping use.

3. The novel incision-free disposable vaginal stress urinary incontinence prevention device according to claim 1, characterized in that, The projectile (1) has no cuts in its shape and is a disposable material.

4. The novel incision-free disposable vaginal stress urinary incontinence prevention device according to claim 1, characterized in that, The projectile (1) has the shape of a bullet or a shuttle structure.

5. The novel incision-free disposable vaginal stress urinary incontinence prevention device according to claim 1, characterized in that, The projectile (1) is composed of a projectile outer shell and a projectile filler, wherein the projectile filler is filled into the projectile outer shell; The outer shell of the projectile is made of a composite of a non-woven fabric layer and a fluff pulp layer; The elastomer filler is medical hydrogel particles.

6. The novel incision-free disposable vaginal stress urinary incontinence prevention device according to claim 1, characterized in that, The maximum distance between the apex of the projectile (2) and the outer side of the elastic projectile (1) is 5-15 mm.

7. The novel incision-free disposable vaginal stress urinary incontinence prevention device according to claim 1, characterized in that, The warhead (2) contains medical-grade silicone particles or latex particles.

8. The novel incision-free disposable vaginal stress urinary incontinence prevention device according to claim 1, characterized in that, The outer surface of the projectile (1) is also provided with an anti-slip network layer (6).

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