A magnetic suction type urethral closure device in the deep penile fascia

Abstract

The present application provides a penis deep fascia inner magnetic suction type urethral closure device, relates to the field of urethral closure, and includes: an implantable arc-shaped metal sheet used for implanting the lower side of the penis root, the implantable arc-shaped metal sheet is provided with a suture hole near the position of the two ends, the suture hole is used for fixing the implantable arc-shaped metal sheet between the deep fascia and the white membrane through a suture line, the middle part of the concave side of the implantable arc-shaped metal sheet is provided with a protruding part, the protruding part is used for corresponding to the urethra and is arranged directly below the urethra; a magnetic attraction underpants outside the body, including a underpants body, the front side of the underpants body is provided with a penis pocket, the inner side of the front wall of the penis pocket is provided with a magnetic attraction patch, the magnetic attraction patch is used for magnetic attraction cooperation with the implantable arc-shaped metal sheet; the problem that the existing technology lacks implantable devices for mild male SUI and has little influence on sexual life is solved.

Description

Technical Field

[0001] This invention belongs to the field of urethral closure, and more specifically, relates to a magnetic urethral closure device within the deep fascia of the penis. Background Technology

[0002] Stress urinary incontinence (SUI) in men refers to the involuntary leakage of urine from the urethra when abdominal pressure suddenly increases, such as during coughing, sneezing, laughing, or mild exercise. According to the International Continence Society (ICS) classification, patients with mild SUI experience only minor leakage during these triggering actions, and their daily activities are generally unaffected. However, persistent leakage still causes significant psychological burden and social distress. These patients require less urethral closure force and do not need strong closure; they prioritize the portability, discreetness, and minimal interference with normal physiological functions of the device.

[0003] Among men with mild SUI, a portion are in their late teens and early twenties, for whom maintaining normal sexual function is a crucial part of their quality of life. Current research indicates that the impact on sexual function resulting from surgical or device intervention for urinary incontinence is a significant factor for this group when choosing a treatment option. An ideal device for treating mild SUI should effectively control urination without substantially interfering with penile erectile function and sexual intercourse; this need has not yet been adequately met in current clinical protocols.

[0004] Currently, the most representative device treatment for male urinary incontinence (SUI) in clinical practice is the AMS 800 artificial urethral sphincter system. This system offers reliable long-term urinary control, but its applicability is primarily for moderate to severe sphincter dysfunction. For SUI patients requiring only mild support, the surgical trauma and complication risks are significantly disproportionate to the severity of their condition: the surgery requires incisions in the perineum, abdomen, and scrotum to implant a hydraulic pump, reservoir, and cuff. Postoperative complications, such as infection, cuff erosion, and mechanical failure, have a cumulative incidence rate of 20%–40%. Furthermore, while the hydraulic pump's squeezing action does not directly affect the corpora cavernosa, multiple surgical scars and scrotal implants have potential negative impacts on the patient's sexual psychology and sexual experience. For patients with mild SUI, this level of invasiveness is difficult to widely accept.

[0005] In existing magnetic urethral closure technologies, such as the urethral closure component for preventing urinary incontinence disclosed in publication number CN101001586B, passive closure is achieved by implanting a permanent magnet compression ring. This scheme places magnets in a ring around the urethra, and the compression range covers the entire circumference of the penile shaft. The compression effect on the corpora cavernosa is not negligible. There is a potential conflict between the engorgement and expansion of the corpora cavernosa during erection and the magnetic compression, which may affect sexual function. At the same time, its compression force is a fixed value, which cannot be finely set for the gentle assistance required for mild SUI. The magnetohydrodynamic urethral valve device disclosed in publication number CN114712030B is relatively large in size, and mechanical interference with erectile tissue is difficult to avoid when placed in the penile segment. In addition, it requires carrying an external magnetic field excitation device, which makes it difficult to conceal in daily life.

[0006] Based on the above analysis, there is currently a lack of implantable device solutions specifically designed for mild male SUI that also have minimal impact on sexual life. Summary of the Invention

[0007] The purpose of this invention is to address the shortcomings of existing technologies by providing a magnetic urethral closure device for deep penile fascia, thus solving the problem that existing urethral closure technologies lack implantable devices that are suitable for mild male SUI and have minimal impact on sexual life.

[0008] To achieve the above objectives, the present invention provides a magnetic urethral closure device for deep penile fascia, comprising: An implantable arc-shaped metal piece is used to be implanted on the lower side of the base of the penis. The implantable arc-shaped metal piece is provided with suture holes near both ends. The suture holes are used to suture and fix the implantable arc-shaped metal piece between the deep fascia and the tunica albuginea through sutures. The concave side of the implantable arc-shaped metal piece is provided with a protrusion in the middle. The protrusion is used to correspond to the urethra and is located directly below the urethra. External magnetic underwear includes an underwear body, a penis pocket is provided on the front side of the underwear body, and a magnetic patch is provided on the inner side of the front wall of the penis pocket. The magnetic patch is used to magnetically engage with the implanted arc-shaped metal plate.

[0009] Optionally, the protrusion is an arc-shaped protrusion structure.

[0010] Optionally, the material of the implantable arc-shaped metal sheet is a medical magnetic material.

[0011] Optionally, the material of the protrusion is a composite material of medical silicone rubber and hydrophilic hydrogel.

[0012] Optionally, the top view projection of the implanted arc-shaped metal sheet is a rectangle with a length of 1-1.5cm and a width of 1-1.2cm, and the thickness of the implanted arc-shaped metal sheet is 0.1-0.2mm.

[0013] Optionally, the diameter of the suture hole is 0.2-0.5 mm.

[0014] Optionally, the root diameter of the protrusion is 5-6 mm, and the protrusion height is 1.5-1.8 mm.

[0015] Optionally, the magnetic patch is a flexible soft magnetic sheet.

[0016] Optionally, the magnetic patch is adhered and fixed to the inner side of the front wall of the penis pocket.

[0017] Optionally, when the magnetic patch is magnetically attached to the implantable arc-shaped metal sheet, the implantable arc-shaped metal sheet elastically deforms and compresses the urethra through the protrusion, with a compression pressure of 40-60 cmH2O. In the demagnetized state, the compression pressure is no more than 10 cmH2O.

[0018] This invention provides a magnetic urethral closure device within the deep fascia of the penis. Its advantages are as follows: This device has an implantable arc-shaped metal plate that can be implanted into the lower part of the penile root. Through suture holes at both ends of the implantable arc-shaped metal plate, it can be fixed within the deep fascia of the penis and outside the tunica albuginea of ​​the corpora cavernosa. This is an independent anatomical space, where the implantable arc-shaped metal plate does not directly contact the corpora cavernosa, nor does it affect the normal engorgement and expansion of the corpora cavernosa, thus ensuring minimal interference with erectile function from an anatomical perspective. To ensure the magnetic attraction of the magnetic patch to the implantable arc-shaped metal plate, a penile pocket is provided on the front of the inner body of the external magnetic underwear for positioning the penis. In a naturally hanging state, the penis is placed within the penile pocket and... The device uses a penile support for positioning, with a matching magnetic patch placed on the inner side of the front wall of the penile support. The magnetic patch and the implanted curved metal plate are positioned on the upper and lower sides of the penis, respectively. When wearing the external magnetic underwear, the attraction between the magnetic patch and the implanted curved metal plate provides gentle, directional pressure on the urethra on the ventral side of the penis, using the protrusions to provide sufficient auxiliary closing force to control mild urinary leakage. During urination or sexual intercourse, simply removing the external magnetic underwear releases the external magnetic force, restoring the urethra to its normal open state. This penile deep fascia magnetic urethral closure device is minimally invasive, requires no hydraulic system, and requires no active operation. Furthermore, while achieving effective urinary control for mild SUI, it maximizes the preservation of the patient's quality of life for sexual intercourse.

[0019] Other features and advantages of the present invention will be described in detail in the following detailed description section. Attached Figure Description

[0020] The above and other objects, features and advantages of the present invention will become more apparent from the more detailed description of exemplary embodiments of the invention in conjunction with the accompanying drawings, wherein the same reference numerals generally represent the same components in the exemplary embodiments of the invention.

[0021] Figure 1 A front view schematic diagram of the implantable arc-shaped metal sheet of a magnetic urethral closure device for penile deep fascia according to an embodiment of the present invention is shown.

[0022] Figure 2 A side view of the implantable arc-shaped metal plate of a magnetic urethral closure device for penile deep fascia according to an embodiment of the present invention is shown.

[0023] Figure 3 A top view schematic diagram of the implantable arc-shaped metal plate of a magnetic urethral closure device for penile deep fascia according to an embodiment of the present invention is shown.

[0024] Figure 4 A schematic diagram of the structure of an external magnetic underwear for a penile deep fascia magnetic urethral closure device according to an embodiment of the present invention is shown.

[0025] Explanation of reference numerals in the attached figures: 1. Implantable curved metal plate; 2. Suture hole; 3. Protrusion; 4. External magnetic underwear; 5. Penis pocket; 6. Magnetic patch; 7. Fixation base. Detailed Implementation

[0026] Preferred embodiments of the invention will now be described in more detail. While preferred embodiments of the invention are described below, it should be understood that the invention can be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that the invention will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art.

[0027] like Figures 1 to 4 As shown, the present invention provides a magnetic urethral closure device for deep penile fascia, comprising: An implantable arc-shaped metal piece 1 is used to be implanted on the lower side of the root of the penis. The implantable arc-shaped metal piece 1 has suture holes 2 near both ends. The suture holes 2 are used to suture and fix the implantable arc-shaped metal piece 1 between the deep fascia and the tunica albuginea through sutures. The implantable arc-shaped metal piece 1 has a protrusion 3 in the middle of the concave side. The protrusion 3 is used to correspond to the urethra and is located directly below the urethra. The external magnetic underwear 4 includes an underwear body, a penis pocket 5 on the front side of the underwear body, and a magnetic patch 6 on the inner side of the front wall of the penis pocket 5. The magnetic patch 6 is used to magnetically engage with the implanted arc-shaped metal plate 1.

[0028] Specifically, to address the problem of existing urethral closure techniques lacking implantable devices specifically designed for mild male SUI with minimal impact on sexual life, this invention provides a magnetic urethral closure device with an implantable arc-shaped metal plate 1. This plate is implanted at the lower side of the penile root. Through suture holes 2 at both ends of the arc-shaped metal plate 1, it can be fixed within the deep fascia of the penis and outside the tunica albuginea of ​​the corpora cavernosa. This is an independent anatomical space, where the implantable arc-shaped metal plate 1 neither directly contacts the corpora cavernosa nor affects its normal engorgement and expansion, ensuring minimal interference with erectile function from an anatomical perspective. To ensure the magnetic attraction of the magnetic patch 6 to the implantable arc-shaped metal plate 1, a penile pocket 5 is provided on the front of the inner body of the external magnetic underwear 4 for positioning the penis. In a suspended position, the device is positioned within the penile pocket 5 and is restrained by the penile pocket 5. The matching magnetic patch 6 is placed on the inner side of the anterior wall of the penile pocket 5, so that the magnetic patch 6 and the implanted arc-shaped metal plate 1 are respectively located on the upper and lower sides of the penis. When wearing the external magnetic underwear 4, the attraction formed between the magnetic patch 6 and the implanted arc-shaped metal plate 1, through the protrusion 3, applies gentle directional pressure to the urethra on the ventral side of the penis, providing an auxiliary closing force sufficient to control mild urinary leakage. When urinating or engaging in sexual intercourse, simply removing the external magnetic underwear 4 will release the external magnetic force and restore the urethra to its normal open state. This penile deep fascia magnetic urethral closure device is not only minimally invasive, requiring no hydraulic system or active operation, but also maximizes the preservation of the patient's quality of life while achieving effective urinary control for mild SUI.

[0029] Optionally, the protrusion 3 is an arc-shaped protrusion structure.

[0030] Specifically, the protrusion 3 adopts a smooth, rounded arc shape, similar to a part of a sphere, and is fixed to the center of the implanted arc-shaped metal sheet 1.

[0031] Optionally, the material of the implantable arc-shaped metal sheet 1 is a medical magnetic material.

[0032] Specifically, the implantable arc-shaped metal patch 1 is made of medical magnetic material to meet the implantation requirements and can form a magnetic attraction with the magnetic patch.

[0033] In this embodiment, it can be made by using medical-grade pure titanium coated neodymium iron boron magnetic powder.

[0034] In other embodiments, medical ferromagnetic materials may also be used.

[0035] Optionally, the material of the protrusion 3 is a composite material of medical silicone rubber and hydrophilic hydrogel.

[0036] Specifically, medical silicone rubber is mixed with hydrophilic hydrogel and medical vulcanizing machine in a set ratio, and then vulcanized at high temperature in a mold to form protrusion 3.

[0037] Optionally, the top view projection of the implanted arc-shaped metal sheet 1 is a rectangle with a length of 1-1.5cm and a width of 1-1.2cm, and the thickness of the implanted arc-shaped metal sheet 1 is 0.1-0.2mm.

[0038] Specifically, the size of the implanted arc-shaped metal plate 1 is matched with the size of the penis, and its thickness is designed to ensure that it can produce appropriate deformation in the magnetic state, so as to achieve gentle pressure on the urethra.

[0039] Optionally, the diameter of the suture hole 2 is 0.2-0.5 mm.

[0040] Specifically, a medical soft silicone molded fixation seat 7 can also be provided at the suture hole 2 location. The fixation seat 7 is attached and fixed to the implantable arc-shaped metal sheet 1, covering the two suture holes 2.

[0041] In this embodiment, the dimensions of the fixing base 7 are 2×2×0.2mm.

[0042] Optionally, the root diameter of the protrusion 3 is 5-6 mm, and the protrusion height is 1.5-1.8 mm.

[0043] Specifically, the size of the protrusion 3 is matched with the size of the urethra to ensure that the urethra can be gently compressed in the magnetic state, so as to promote the urethra to reach a closed state.

[0044] Optionally, the magnetic patch 6 is a flexible magnetic sheet.

[0045] Specifically, the flexible magnetic sheet is set on the external magnetic underwear 4, which can meet the set flexible deformation requirements; the magnetic field strength of the magnetic patch 6 can be set into various types as needed to meet the needs of different degrees of urethral closure.

[0046] Optionally, the magnetic patch 6 is adhered and fixed to the inner side of the anterior wall of the penis pocket 5.

[0047] Specifically, the magnetic patch 6 can be fixed by adhesive, or it can be peeled off or replaced.

[0048] Optionally, when the magnetic patch 6 is magnetically attached to the implantable arc-shaped metal sheet 1, the implantable arc-shaped metal sheet 1 elastically deforms and compresses the urethra through the protrusion 3, with a compression pressure of 40-60 cmH2O. In the demagnetized state, the compression pressure is no more than 10 cmH2O.

[0049] Specifically, two anchoring points are formed at the two suture holes 2. Under the action of the two anchoring points, when the external magnetic underwear 4 is worn and the implanted arc-shaped metal piece 1 is in a magnetic state, the implanted arc-shaped metal piece 1 undergoes upward elastic deformation, and the protrusion 3 achieves appropriate pressure on the urethra, thus achieving the closure of the urethra. When the external magnetic underwear 4 is removed and the magnetic state is released, the implanted arc-shaped metal piece 1 relies on its own elasticity to restore its shape, relieve the pressure on the urethra, and does not affect normal urination and ejaculation and other physiological activities.

[0050] In this embodiment, during the fabrication of the penile deep fascia magnetic urethral closure device provided by the present invention, the following steps are taken regarding the fabrication of the implantable arc-shaped metal sheet 1: (1) Molding of implantable arc-shaped metal sheet 1: medical pure titanium foil is selected to coat neodymium iron boron magnetic powder, which is formed by isostatic pressing, vacuum sintering, hot pressing composite, and wire cutting into 1.5cm×1cm arc-shaped sheet with an arc surface curvature radius of 8-12mm. (2) Preparation and installation of fixation seat 7: The medical soft silicone pre-formed 2mm×2mm×0.2mm fixation seat 7 is bonded to the upper left and upper right ends of the metal sheet, covering the reserved 0.5mm suture hole 2; (3) Forming of protrusion 3: Medical silicone rubber, hydrophilic hydrogel and medical vulcanizing agent are injected into the inferior spherical mold according to the proportion, and after high temperature vulcanization, they are bonded to the center of the inner side of the implantable arc-shaped metal sheet 1. (4) Sterilization and packaging: Sterilized by gamma ray irradiation, aseptically sealed packaging, shelf life of 3 years.

[0051] For the preparation of external magnetic underwear 4: (1) Underwear body: medical cotton-nylon blended fabric, cut and sewn into a male penis pocket style 5 underwear; (2) Magnetic patch 6: Neodymium iron boron flexible magnetic powder and silicone substrate are mixed in proportion and pressed into a flexible soft magnetic sheet of 2cm×1.5cm×0.3mm with a magnetic field strength of 200mT, and encapsulated in a medical polyurethane film. (3) Assembly and positioning: Fix the magnetic patch 6 to the center of the inner side of the front wall of the penis pocket 5 of the underwear, and ensure that the center of the magnetic patch is aligned with the center of the implantable arc-shaped metal piece 1 when wearing.

[0052] The surgical implantation procedure includes: (1) Preoperative preparation: The patient is placed in a supine position, routinely disinfected and draped, and local anesthesia is administered; (2) Surgical incision: A longitudinal incision of about 2 cm is made in the midline of the ventral side of the penis. The skin, subcutaneous tissue and superficial fascia are cut in sequence to expose the deep fascia of the penis. (3) Insertion of the implantable arc-shaped metal sheet 1: bluntly separate a 2cm×1.5cm gap between the deep fascia and the tunica albuginea, insert the implantable arc-shaped metal sheet 1, and adjust the protrusion 3 so that it faces the center of the corpus spongiosum with the arc surface of the protrusion facing upward and adhering to the outer wall of the urethra. (4) Suture fixation: Use absorbable polylactic acid sutures to pass through the upper left and upper right fixation seats 7 and suture holes 2, and suture fix with the deep fascia with 2 stitches each; (5) Close the incision: Suture the superficial fascia, subcutaneous tissue and skin layer by layer, cover with sterile dressing, and remove the sutures 5-7 days after the operation.

[0053] The daily usage method is as follows: Urine control: The patient wears external magnetic underwear 4, places the penis inside the penile pocket 5 and lets it hang naturally. The magnetic patch 6 and the implanted arc-shaped metal plate 1 inside the body generate directional magnetic attraction. The magnetic field causes the implanted arc-shaped metal plate 1 to deform upwards in an arc shape. The protrusion 3 pushes upwards against the urethral sponge, closing the urethra and stabilizing the pressure at 40-60 cmH2O, effectively preventing urine leakage. Wearing the underwear automatically completes the urine control without any manual operation.

[0054] Urinary control: The patient can directly remove the magnetic underwear, the external magnetic field disappears immediately, the implanted arc-shaped metal piece 1 returns to its original position instantly due to its own elasticity, the protrusion 3 detaches from the urethra, the urethra returns to a fully open state, and urine is discharged smoothly.

[0055] Compared to traditional implantable urethral closure devices, this deep penile fascia magnetic urethral closure device: (1) Less surgical trauma: The surgical incision is only 2cm, there is no need to wrap the urethra, and recovery takes 5-7 days after surgery, making it suitable for elderly and weak patients; (2) Magnetic attraction is precise and stable: The directional design, combined with the Penis Pocket 5-style underwear, automatically aligns when worn, avoiding displacement and failure; (3) The compression pressure is safe and precise: it is controlled at 40-60 cmH2O, and there is no risk of urethral necrosis or hyperplasia with long-term use; (4) Permanent and reliable fixation: The double-point suture fixation is fixed to the deep fascia, and it will not shift or rotate for a long time; (5) Extremely simple operation: simply put on or take off underwear to switch between holding urine and urinating, operation time ≤15s; (6) Extremely simple structure and low cost: There are no complex and precision parts, and the cost of use is far lower than that of AMS 800.

[0056] The various embodiments of the present invention have been described above. These descriptions are exemplary and not exhaustive, nor are they limited to the disclosed embodiments. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the described embodiments.

Claims

1. A magnetic urethral closure device for deep penile fascia, characterized in that, include: An implantable arc-shaped metal piece is used to be implanted on the lower side of the base of the penis. The implantable arc-shaped metal piece is provided with suture holes near both ends. The suture holes are used to suture and fix the implantable arc-shaped metal piece between the deep fascia and the tunica albuginea through sutures. The concave side of the implantable arc-shaped metal piece is provided with a protrusion in the middle. The protrusion is used to correspond to the urethra and is located directly below the urethra. External magnetic underwear includes an underwear body, a penis pocket is provided on the front side of the underwear body, and a magnetic patch is provided on the inner side of the front wall of the penis pocket. The magnetic patch is used to magnetically engage with the implanted arc-shaped metal plate.

2. The penile deep fascia magnetic urethral closure device according to claim 1, characterized in that, The protrusion is an arc-shaped protrusion structure.

3. The penile deep fascia magnetic urethral closure device according to claim 1, characterized in that, The material of the implantable arc-shaped metal sheet is a medical magnetic material.

4. The penile deep fascia magnetic urethral closure device according to claim 1, characterized in that, The material of the protrusion is a composite material of medical silicone rubber and hydrophilic hydrogel.

5. The penile deep fascia magnetic urethral closure device according to claim 1, characterized in that, The top view projection of the implanted arc-shaped metal sheet is a rectangle with a length of 1-1.5cm and a width of 1-1.2cm, and the thickness of the implanted arc-shaped metal sheet is 0.1-0.2mm.

6. The penile deep fascia magnetic urethral closure device according to claim 1, characterized in that, The diameter of the suture hole is 0.2-0.5 mm.

7. The penile deep fascia magnetic urethral closure device according to claim 2, characterized in that, The root diameter of the protrusion is 5-6 mm, and the protrusion height is 1.5-1.8 mm.

8. The penile deep fascia magnetic urethral closure device according to claim 1, characterized in that, The magnetic patch is a flexible soft magnetic sheet.

9. The penile deep fascia magnetic urethral closure device according to claim 1, characterized in that, The magnetic patch is adhered and fixed to the inner side of the front wall of the penis pocket.

10. The penile deep fascia magnetic urethral closure device according to claim 1, characterized in that, When the magnetic patch is magnetically attached to the implantable arc-shaped metal sheet, the implantable arc-shaped metal sheet elastically deforms and compresses the urethra through the protrusion, with a compression pressure of 40-60 cmH2O. In the demagnetized state, the compression pressure is no more than 10 cmH2O.

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